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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  
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.

 
Event Description

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

 
Search Alerts/Recalls

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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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