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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC OMNIBED GIRAFFE WARMER, INFANT RADIANT

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GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC OMNIBED GIRAFFE WARMER, INFANT RADIANT Back to Search Results
Model Number 6650-0077-901
Device Problems Device Emits Odor (1425); Overheating of Device (1437)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/25/2017
Event Type  malfunction  
Event Description
Approximately one year ago, a "burning smell" was reported on an infant warmer to clinical engineering. The patient was removed and the device was removed from service for repair. The report was confirmed and a thermal imaging device was used to find the defective component. Ordered and received a new component and installed. The device was fully tested and returned to service. Side note: approximately 1 month ago, again a "burning smell" was reported on a similar infant warmer to clinical engineering. This was not the same infant warmer but a close sn. A separate incident report and report was created for that one with the identification and problem details in it.
 
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Brand NameOMNIBED GIRAFFE
Type of DeviceWARMER, INFANT RADIANT
Manufacturer (Section D)
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC
9900 innovation drive
wauwatosa WI 53226
MDR Report Key7901427
MDR Text Key121453052
Report Number7901427
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 09/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number6650-0077-901
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/06/2018
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer09/24/2018
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

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