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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OHMEDA MEDICAL GIRAFFE WARMER WARMER, INFANT RADIANT

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OHMEDA MEDICAL GIRAFFE WARMER WARMER, INFANT RADIANT Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Hematoma (1884); Skull Fracture (2077)
Event Type  Injury  
Manufacturer Narrative
Ge healthcare's investigation into the reported occurrence is ongoing. A follow-up report will be issued when the investigation has been completed. Incident date: (b)(6) 2018. Report source: (b)(4). Device evaluation anticipated, but not yet begun.
 
Event Description
The hospital reported that an infant was heard crying in room 23. Within 1 minute, an rn entered the room and found the infant bundled lying on his back on the floor with his head closest to the foot of the bed, vertically in line with the bed. Infant fell approx. 3-4 feet. Medical assessment of the patient showed a quarter sized hematoma over right parietal bone of skull. Ct exam showed soft tissue/scalp swelling at the high right parietal region with non-displaced fracture of the right parietal bone. There was no acute intracranial hemorrhage or mass.
 
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Brand NameGIRAFFE WARMER
Type of DeviceWARMER, INFANT RADIANT
Manufacturer (Section D)
OHMEDA MEDICAL
8880 gorman rd
laurel, MD 20723
Manufacturer Contact
john szalinski
3000 n grandview blvd.
waukesha, WI 
MDR Report Key8365705
MDR Text Key136985295
Report Number1121732-2019-00002
Device Sequence Number1
Product Code FMT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 10/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/20/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/1970
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberFMI32067

Patient Treatment Data
Date Received: 02/25/2019 Patient Sequence Number: 1
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