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U.S. Department of Health and Human Services

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

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OHMEDA MEDICAL GIRAFFE WARMER INFANT RADIANT WARMER Back to Search Results
Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Skull Fracture (2077)
Event Date 06/02/2017
Event Type  Injury  
Manufacturer Narrative
The hospital initially reported the side wall had not been latched when the infant rolled against it, causing the patient to fall. The patient reportedly sustained a fractured skull. The ct scan of the patient was read by the hospital neurosurgeon who reported no further medical intervention was deemed necessary. No follow up or neurology appointments were scheduled. No extended hospitalization secondary to the fall was required. The hospital later reported to ge healthcare that, after weighing the patient and having placed the patient off center on the mattress, the caregiver moved away from the patient without latching the bed side wall. The side wall did not give way as initially reported. Ge healthcare carefully reviewed the side wall design, looking for any possibility of the side wall remaining slightly attached but not latched or if the side wall could be in a position other than unlatched and folded down, or upright and latched. Results showed that the side wall can either be in an unlatched and folded down position, or upright and latched, but could not be in an intermediary position. Ge healthcare concludes that the device did not malfunction. It appears the side wall was not upright and latched when the infant rolled off the bed. The hospital reported the unit was evaluated by a hospital biomed and found to function within specification. The hospital declined ge healthcare¿s offer to perform a checkout of the unit. The hospital reported that the unit has been returned to service.
 
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. Device evaluation anticipated, but not yet begun.
 
Event Description
Subsequent to weighing the infant, the staff member reportedly placed the infant on the mattress, just off center. The infant was reportedly startled and rolled towards the unlocked side wall of the warmer. The door panel opened, and the patient fell to the floor. It was reported that a cat scan was performed, confirming a skull fracture. The hospital neurosurgeon reviewed the scan and determined no further medical intervention was required.
 
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Brand NameGIRAFFE WARMER
Type of DeviceINFANT RADIANT WARMER
Manufacturer (Section D)
OHMEDA MEDICAL
8880 gorman rd
laurel, MD
Manufacturer Contact
joseph seliga
3000 n grandview blvd.
waukesha, WI 
MDR Report Key6802032
MDR Text Key248555234
Report Number1121732-2017-00001
Device Sequence Number1
Product Code FMT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122267
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2017
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 Received07/21/2017
Was Device Evaluated by Manufacturer? No Answer Provided
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

Patient Treatment Data
Date Received: 08/17/2017 Patient Sequence Number: 1
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