The recall applies to all lot numbers with the model numbers 2063568001xxxxxx, 2063570001xxxxxx, m1112198xxxxxx, and m1118179xxxxxx, manufactured between october 1, 2007 to february 28, 2019 and distributed between october 1, 2007 to february 28, 2019. Illustrated parts board assembly revision number air circulation motor air flow sensor dc output warmer heater control inc heater control 50 49 motor trans sec ebase. Chemical compatibility for anesthesia and respiratory devices on this site only applies to outer surfaces. With simple and easytouse features such as handsfree alarm silence, fullcolor display, and an integrated scale, your caregivers can focus on the most critical aspects of their jobcaring for newborns and their families. An innovative recessed heater design lets you see and access your patients, and it keeps patients warm and content while keeping you cool and comfortable. Baby susan rotating and bidirectional mattress thanks to the baby susan patented technology, clinicians can easily reposition the baby, reducing negative touches and stimulation to the newborn. Jul 12, 2019 ge healthcare is recalling the giraffe and panda ires infant warmers because the bedside panels and latch areas of the warmers can crack or break if the unit is moved using the bedside panels instead of the front or rear maneuvering handle see figures below. Ge healthcare 510k 21 2010 food and drug administration. It has a bed tilt and the option of an inbed weighing scale that is operated from the control panel screen. This voluntary field corrective action is being initiated after ge healthcare. Education services maternal infant care ge healthcare.
Ge healthcare giraffe warmers for neonatal intensive care helping make sick babies well the giraffe warmer is designed to meet the needs of the nicu patient and clinician along with the giraffe incubator and giraffe omnibed. Panda iresand giraffe warmers service manual manualzz. If you add items to cart and submit your order without the. It is placed all around with the side panels and it has bed elevation mechanisms, which are. Ge healthcare recalls giraffe incubators and omnibeds. With simple and easytouse features such as handsfree alarm silence, fullcolor display, and an integrated scale, your caregivers can focus on the most critical aspects of their. Its a solution that will help you provide better care in a beautiful environment. However, there are still many people who also dont once reading. Thanks to the baby susan patented technology, clinicians can easily reposition the baby, reducing negative touches and stimulation to the newborn. The purpose of this inbed scale is for convenient and efficient weighing of the infant. Once youre in that page, click the tab at the top life support.
Healthcare professionals using the giraffe or panda ires infant warmer what to do on march 15, 2019, ge healthcare gehc sent an urgent medical device correction notification letter to customers. Giraffe omnibed carestation designed with babies, and their families in mind, the giraffe omnibed carestation creates a controlled, protected microenvironment for peaceful, fast healing. Ge healthcare giraffe incubator service manual on april 22, 2019 by adahy le environment to grow and thrive ge healthcare ohmeda giraffe infant giraffe omnibed ge healthcare ge healthcare ge healthcare ohmeda giraffe infant. On the parts list below, click on a picture or part name for more information. Ge healthcare is recalling the giraffe and panda ires infant warmers because the bedside panels and latch areas of the warmers can crack or break if the unit is moved using the bedside panels instead of the front or rear maneuvering handle see figures below. Telemetry parts neonatal incubators ge healthcare recalls giraffe and panda neonatal incubator infant radiant warmer bilisoft led phototherapy system ge healthcarege healthcare giraffe family user manual page 3 12ge giraffe omnibed double walled incubator and infant warmergiraffe incubator manualzzgiraffe accessories giraffecare and clinical. Ge giraffe warmer operation and maintenance manual rev e. Filing a ge healthcare infant warmer lawsuit could be an option if your baby sustained serious injuries after falling from a giraffe or panda ires radiant infant warmer. The handsfree alarm silencing feature lets you easily control alarms by simply moving your hand in front of the sensor. The panda warmer allows you to focus on caring for your patients.
With its fiberoptic light pipe and innovative gooseneck design, its easy to position the blue spot pt to deliver. Designed with babies, and their families in mind, the giraffe omnibed carestation creates a controlled, protected microenvironment for peaceful, fast healing. Ge healthcare has issued a recall for all giraffe warmers and panda ires warmers, used by hospitals and clinicians. Ge healthcare the giraffe standalone infant resuscitation system gives you fast and easy access to an integrated solution you need for the effective resuscitation of newborns. Jul 15, 2019 ge healthcare has issued an infant warmer recall for its giraffe and panda ires infant warmers. Vapotherm precision flow in service video customer training and onboarding. The logiq e10 ultrasound system provides a new standard in imaging, advanced tools, and enhanced workflow ergonomics so clinicians can scan, diagnose, and treat a wide range of patients across a broad spectrum of conditions. The panda and giraffe warmers are each offered in a bedded model. Maternalinfant care clinical education institute ge healthcare.
Headquartered in the united kingdom, ge healthcare is a unit of general electric company nyse. Ge healthcare is recalling the giraffe incubator, giraffe omnibed, giraffe incubator carestation, and giraffe omnibed carestations because the bedside panels can be upright and look closed but not be securely latched. Call 8004371171 enter opt 1 for the first three prompts, and have your system id available. Contact ge healthcare for an additional copy of the device manual if required. The subject of this premarket submission, giraffe and panda warmers, used with shuttle, did not require clinical studies to support substantial equivalence. The recall applies to all lot numbers with the model numbers 2063568001xxxxxx, 2063570001xxxxxx, m1112198xxxxxx, and m1118179xxxxxx, manufactured between october 1, 2007 to february 28, 2019 and distributed between october 1, 2007 to. Easily portable, it can be setup virtually anywhere you need it, from labor and delivery to nicu to the wellbaby nursery. Ires panda warmer ge healthcare giraffe warmer medwrench.
Healthcare providers can give care to the baby through holes in the sides of the incubator, also called portholes. Ge giraffe incubator covers best image giraffe in the word. Ge healthcares suite of labor and delivery products has been designed to support your mission of family centered care. The recessed heater design gives you convenient control, visibility and access even to perform procedures such as xrays and surgery. Class 1 device recall giraffe and panda warmer tpiece. The food and drug administration has announced two class i recalls, the most serious type of recalls. May 31, 2012 giraffe standalone infant resuscitation system by ge healthcare combines essential capabilities in a single, compact solution. Easily convert the giraffe omnibed carestation into a radiant warmer without disturbing the baby by utilizing the onetouch canopy lift and foot pedal. Ge recently recalled both infant warmers, following hundreds of complaints regarding broken bedside panelslatches and at least two infant injuries.
It is placed on the mattress support plate and all around with the side panels. The purpose of this is to ensure the infant is restful, comfortable and safe. Ge healthcare, llc recalls giraffe infant warmers and panda i. Cl i recalls ge healthcare giraffe infant warmers and panda. View and download ge giraffe service manual online. All lot numbers of ge healthcares giraffe infant warmers and panda ires infant warmers because the bedside panels and latch areas of the warmers can crack or break if the unit is moved using the bedside panels instead of the front or rear maneuvering handle.
Ge healthcare has received the mdea award for the outstanding, innovative features of the panda warmer. The giraffe warmer delivers powerful uninterrupted thermal performance with fullyintegrated features and options. Patient and userfriendly the blue spot pt supports developmental care measures while promoting efficient patient management. Ge healthcare giraffe incubator service manual best image. Ge healthcare infant warmer lawsuit ge infant warmer recall. With panda warmers we have integrated the best technology with superb design. The panda mattress is one of the assembly parts that make up the bed assembly in the panda ires warmer. Giraffe warmer ge healthcare giraffe family user manual. Dont bother trying to filter out anything that way you can see all the manuals they have, maybe you need another one just in case. The revolutionary heater design eliminates a large overhead heater making it easier to observe the. Giraffe blue spot pt lite phototherapy system ge healthcare.
The giraffe warmer brings you a solution in high acuity settings with powerful uninterrupted thermal performance that ensures a comfortable and developmentallysupportive environment for the baby. Ge giraffe warmer operation and maintenance manual rev e pdf. Soma tech intl 166 highland park drive bloomield, ct 06002 usa phone. For more information about ge healthcare, visit our website at. Page 26 giraffe warmer, but the procedure light is optional. If you start with the canopy open, or open the bed during the first minutes after start up, and you do not select a control mode, the graphics screen will show the warm up mode message and the radiant heater will automatically run at 100% power. The standalone infant resuscitation system gives you fast, easy and integrated access to critical equipment you need for the safe and effective resuscitation of newborns. Ge healthcare maternal infant care this is ges inservice video on our new giraffe incubator.
Follow your devices user manual for internal cleaning and disinfection instructions. Ge healthcare has issued an infant warmer recall for its giraffe and panda ires infant warmers. Ge giraffe incubator covers on december 19, 2019 by adahy giraffe platfrom brochure english cover air inlet embly gh and giraffe incubator whole trader from ge healthcare the giraffe family accessories. It connects to the bed and provides electrical power to the bed and other auxiliary equipment, as well as provisions for medical gas management, required for patient care during intrahospital transport. The giraffe warmer provides a warm, comfortable, developmentally supportive environment for the baby. Page 15 ge healthcare does not imply in anyway that ge healthcare deems said. A warm, comfortable and developmentallysupportive environment for the baby. Ask your ge healthcare representative for details today. Operation and maintenance manual ge giraffe warmer operation and maintenance manual rev e. Ge giraffe standalone infant resuscitation system youtube. Ge healthcare giraffe incubator service manual best. The oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly. Worldwide, ge healthcare employees are committed to serving healthcare professionals and their patients in more than 100 countries.
Ge healthcare giraffe omnibed carestation or today. Giraffe warmer warmers perinatal care categories ge. Ge healthcare has received the medical device excellence award mdea for the outstanding, innovative features of the giraffe warmer, which allow you to. Voluntary field corrective action issued for ge healthcares. The model type is indicated on the label and on the devices splash screen.
Le environment to grow and thrive ge healthcare ohmeda giraffe infant giraffe omnibed ge healthcare ge healthcare ge healthcare ohmeda giraffe infant. Transportable power source that facilitates the mobility of ge healthcare giraffe beds and panda warmers within a hospital building. Giraffe platfrom brochure english cover air inlet embly gh and giraffe incubator whole trader from ge healthcare the giraffe family accessories. Jul 16, 2019 filing a ge healthcare infant warmer lawsuit could be an option if your baby sustained serious injuries after falling from a giraffe or panda ires radiant infant warmer. Giraffe standalone infant resuscitation system by ge healthcare combines essential capabilities in a single, compact solution. Illustrated parts board assembly revision number air circulation motor air flow sensor dc output warmer heater control inc heater control 50 49 motor trans sec.
Giraffe shuttle transportable power source that facilitates the mobility of ge healthcare giraffe beds and panda warmers within a hospital building. Giraffe warmer warmers perinatal care ge healthcare. The tpiece resuscitation system ventilator, emergency powered resuscitatorpanda bag and mask resuscitation system provides the basic equipment required for pulmonary resuscitation of infants. Giraffe blue spot pt lite phototherapy system fusion healthcare. Wain229 ge healthcare panda ires and giraffe warmers service. Giraffe warmers the giraffe shuttle is a transportable power source that is an accessory to giraffe and panda1 beds.
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