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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC. (PNC) RESUSCITAIRE RW82/WBR82 INFANT RADIANT WARMER

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DRAEGER MEDICAL SYSTEMS, INC. (PNC) RESUSCITAIRE RW82/WBR82 INFANT RADIANT WARMER Back to Search Results
Model Number RW82
Event Date 01/03/2008
Event Type  Injury  
Event Description

It was reported that: a nine month old baby was placed in a rw82 for about 30 mins using the manual mode. During this time, the baby was slightly burned.

 
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Brand NameRESUSCITAIRE RW82/WBR82
Type of DeviceINFANT RADIANT WARMER
Manufacturer (Section D)
DRAEGER MEDICAL SYSTEMS, INC. (PNC)
Manufacturer Contact
gale winarsky
3135 quarry rd.
telford , PA 18969
2156602239
MDR Report Key996580
Report Number2510954-2008-00001
Device Sequence Number1
Product CodeFMT
Report Source Manufacturer
Source Type Distributor
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 02/08/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/08/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberRW82
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received01/09/2008
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/01/1996
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 02/08/2008 Patient Sequence Number: 1
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