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Adverse Event Report

DRAGER MEDIZINTECHNIK GMBH EVITA 4 VENTILATOR, CONTINUOUS   back to search results
Model Number EVITA 4
Device Problem Device, incorrect care/use of
Event Date 10/07/1998
Event Type  Other   Patient Outcome  Other;
Event Description

It was reported that the ventilator indicated the pressure curve on the display but did not ventilate.

 
Manufacturer Narrative

See section h10.

 
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Brand NameEVITA 4
Type of DeviceVENTILATOR, CONTINUOUS
Baseline Brand NameEVITA 4
Baseline Generic NameVENTILATOR, CONTINUOUS
Baseline Catalogue Number8411900
Baseline Model NumberEVITA 4
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 Key188848
MDR Report Key194375
Event Key182694
Report Number9611500-1998-00015
Device Sequence Number1
Product CodeCBK
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/22/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/26/1998
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberEVITA 4
Device Catalogue Number8411740
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/23/1998
Distributor Facility Aware Date10/22/1998
Device Age6 mo
Event Location Hospital
Date Manufacturer Received10/08/1998
Was Device Evaluated By Manufacturer? No
Date Device Manufactured03/01/1998
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 February 28, 2009

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