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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. GIRAFFE WARMER WARMER, INFANT RADIANT

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DATEX-OHMEDA, INC. GIRAFFE WARMER WARMER, INFANT RADIANT Back to Search Results
Model Number M1118179
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Skull Fracture (2077)
Event Date 05/28/2020
Event Type  Injury  
Manufacturer Narrative
On 02-jun-2020 ge healthcare (gehc) was notified by (b)(6) hospital in (b)(6) that a (b)(6) old, ((b)(6) at birth) male was discovered on the floor by cleaning staff. Based on our investigation and thorough examination of the device, gehc concluded that the device was functioning as intended, did not malfunction, and met all specifications. Ge healthcare does not believe that the device caused or contributed to the patient fall. Based on information provided by the hospital: no one observed the patient fall. Imaging tests were performed, and it was found that the patient had a fractured skull. No cerebellar bleed was identified. To date, no additional clinical interventions have been necessary due to the fall. The hospital placed the device back into service the day after the incident occurred. An investigation of the handling of the patient and workflow is ongoing at the customer site. A follow-up report will be issued when the investigation has been completed. The ge field engineer thoroughly examined the device in question within 48 hours of being informed of the incident: the device was thoroughly examined, including but not limited to a thorough examination of all device walls, wall latches, bed assembly, and overall functionality of the device. The device was found to meet all specifications and no device malfunction or breakage was found. The field engineer also confirmed that all labeling associated with fmi (b)(4) ((b)(4)), including device labels and posters were present and appropriately applied per fmi (b)(4) instructions.
 
Event Description
On 02-jun-2020 ge healthcare (gehc) was notified by a hospital in (b)(6) that a (b)(6) old, ((b)(6) at birth) male was discovered on the floor by cleaning staff. Based on our investigation and thorough examination of the device, gehc concluded that the device was functioning as intended, did not malfunction, and met all specifications. Ge healthcare does not believe that the device caused or contributed to the patient fall.
 
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Brand NameGIRAFFE WARMER
Type of DeviceWARMER, INFANT RADIANT
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer Contact
jason kelly
3000 n grandview blvd.
waukesha, WI 
MDR Report Key10201306
MDR Text Key198285961
Report Number2112667-2020-01799
Device Sequence Number1
Product Code FMT
Combination Product (y/n)N
PMA/PMN Number
K122267
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 08/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberM1118179
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/21/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/04/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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