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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRAGER MEDICAL AG & CO. KG EVITA 4 VENTILATOR CONTINUOUS

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DRAGER MEDICAL AG & CO. KG EVITA 4 VENTILATOR CONTINUOUS Back to Search Results
Event Date 04/23/2010
Event Type  Death  
Event Description

It was reported that the evita 4 stopped ventilation without alarms. This reportedly caused that the pt died.

 
Manufacturer Narrative

The device components and add'l info were requested for investigation, but not yet rec'd. Investigation results will be reported in a follow up report.

 
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Brand NameEVITA 4
Type of DeviceVENTILATOR CONTINUOUS
Manufacturer (Section D)
DRAGER MEDICAL AG & CO. KG
moislinger allee 53-55
lubeck D-23 542
Manufacturer Contact
frank clanzett
moislinger allee 53-55
lubeck  23542
GERMANY   23542
518822868
MDR Report Key1692322
Report Number9611500-2010-00021
Device Sequence Number1
Product CodeCBK
Report Source Manufacturer
Source Type User facility,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 05/07/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/07/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/30/2010
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/01/2007
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 05/07/2010 Patient Sequence Number: 1
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