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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  
Manufacturer Narrative

The customer has not allowed draeger to inspect the device. It was reported that the unit was being used in the manual heating mode. In this mode, the user should constantly observe the infant, and monitor the infant temperature to avoid over heating or under heating. The device is designed so that when in manual mode if the warmer is in operation for longer than 10 mins, the check pt indicator illuminates and the alarm sounds. The indicator remains illuminated, and the alarm continues to sound every 30 seconds for 5 mins or until the user acknowledges the alarm. If the alarm has not been acknowledged for a total of 15 mins, the heater will shut off and a three level alarm sounds continuously. The user must acknowledge this alarm to restart the heater output. The investigation has not determined any product malfunction. The reported pt injury may potentially be due to user error.

 
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 F)
DRAEGER MEDICAL SYSTEMS, INC. (PNC)
Manufacturer (Section D)
DRAEGER MEDICAL SYSTEMS, INC. (PNC)
Manufacturer Contact
gale winarsky
3135 quarry rd.
telford , PA 18969
(215) 660 -2239
Device Event Key966260
MDR Report Key996580
Event Key955669
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
Was The Report Sent To Manufacturer? 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
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

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