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U.S. Department of Health and Human Services

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

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DATEX-OHMEDA, INC. GIRAFFE INFANT WARMER WARMER, INFANT RADIANT Back to Search Results
Model Number M1118179
Device Problem Break (1069)
Patient Problems Fall (1848); Skull Fracture (2077); Swelling (2091)
Event Date 12/29/2018
Event Type  Injury  
Event Description
Infant heard crying in room 23. Within 1 minute, an rn entered room and found infant bundled lying on back on floor with his head closest to the foot of the bed vertically in line with the bed. Infant fell approx. 3-4 feet. Foot rail of warmer found in down position. It appears that the bed was broken--staff unaware of this. It appears so though the latch on the bottom side rail gave a way and the infant slide off the bed and the bed was on a 30 degree incline. Infant immediately placed back on bed. Resident neonatologist called to room. Physical neurological assessment of infant completed. Quarter size hematoma over right parietal bone of skull. No other apparent injuries noted. Neuro exam normal. Infant alert and quiet. Ct of brain ordered. Ct shows soft tissue/scalp swelling at the high right parietal region with nondisplaced fracture of the right parietal bone. No acute intracranial hemorrhage or mass effect. Locking slot mechanism on foot rail of warmer with visible breakage. Upon testing, the foot rail closes and secures but it is easily dislodged making it fall down. Infant transferred to a new, unbroken warmer. Broken warmer removed and sequestered. All other warmers on unit inspected for similar damage. Mother of infant notified by 0830. Mother and extended family at bedside at 0910. Mother informed of all findings immediately. Mother requesting transfer of infant to another hospital. Infant placed on brainz monitor to assess for any seizure activity. Neuro checks every 2 hours. Trauma workup of infant ordered. No additional fractures or injuries noted. Infant remains alert, vss, no seizure activity noted, taking a bottle of formula for feeding. Mother of infant holding infant to feed.
 
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Brand NameGIRAFFE INFANT WARMER
Type of DeviceWARMER, INFANT RADIANT
Manufacturer (Section D)
DATEX-OHMEDA, INC.
8880 gorman road
laurel MD 20723
MDR Report Key8284502
MDR Text Key134318121
Report Number8284502
Device Sequence Number1
Product Code FMT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/07/2019,01/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM1118179
Device Catalogue NumberM1118179-024446
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/07/2019
Device Age4 YR
Event Location Hospital
Date Report to Manufacturer01/29/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/29/2019 Patient Sequence Number: 1
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