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Adverse Event Report

DRAGER BABYTHERM 8000 HEATED BASSINET   back to search results
Model Number BABYTHERM 8000 WB
Event Date 07/23/1997
Event Type  Malfunction   Patient Outcome  Other;
Event Description

It was reported that a restless and strong baby lifted and opened one side panel.

 
Manufacturer Narrative

Drager intesively investigated the type of devices involved in the event. The user manual recommended to use the add'l inner panels of the babytherm 8000 to protect the baby from falling out of the babytherm. In the reported event a very active and strong baby was lying in the heated bassinet. Drager medizintechnick gmbh decided to clarify the statement in the user manual mentioned above and will recommend to always use the inner panels with active infants. The customers will also be informed by drager.

 
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Brand NameBABYTHERM 8000
Type of DeviceHEATED BASSINET
Baseline Brand NameBABYTHERM 8000
Baseline Generic NameHEATED BASSINET
Baseline Catalogue NumberFR 00048
Baseline Model NumberBABYTHERM 8000 WB
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
DRAGER
moislinger allee 53-55
luebeck
GERMANY 23542
Manufacturer (Section D)
DRAGER
moislinger allee 53-55
luebeck
GERMANY 23542
Manufacturer (Section G)
DRAEGER MEDICAL AG & CO. KG
53/55 moislinger allee
luebeck
GERMANY 23542
Device Event Key115063
MDR Report Key117324
Event Key110325
Report Number9611500-1997-00008
Device Sequence Number1
Product CodeFMT
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/28/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/28/1997
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberBABYTHERM 8000 WB
Device Catalogue NumberFR 00048
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/29/1997
Distributor Facility Aware Date08/28/1997
Device Age4 mo
Event Location Hospital
Date Manufacturer Received08/14/1997
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/01/1997
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Database last updated on January 30, 2009

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