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Adverse Event Report

DRAGER MEDIZINTECHNIK GMBH BABYTHERM 8000 HEATED BASSINET   back to search results
Model Number BABYTHERM 8000
Event Date 04/08/1999
Event Type  Malfunction   Patient Outcome  Other;
Event Description

See initial report.

 
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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
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
DRAGER MEDIZINTECHNIK GMBH
moislinger allee 53-55
luebeck
GERMANY 23542
Manufacturer (Section D)
DRAGER MEDIZINTECHNIK GMBH
moislinger allee 53-55
luebeck
GERMANY 23542
Manufacturer (Section G)
DRAEGER MEDICAL AG & CO. KG
53/55 moislinger allee
luebeck
GERMANY 23542
Device Event Key213749
MDR Report Key220397
Event Key206802
Report Number9611500-1999-00012
Device Sequence Number1
Product CodeFMT
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/21/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/21/1999
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberBABYTHERM 8000
Device Catalogue NumberFR 00048
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Device Agena
Event Location Not Applicable
Date Manufacturer Received04/08/1999
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/01/1998
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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