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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA EVITA 4 VENTILATORS, INTENSIVE CARE

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DRÄGERWERK AG & CO. KGAA EVITA 4 VENTILATORS, INTENSIVE CARE Back to Search Results
Catalog Number 8411740
Device Problems Premature Discharge of Battery (1057); Gas Output Problem (1266); Decrease in Pressure (1490); Failure to Deliver (2338); Complete Loss of Power (4015)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

 
Event Description

It was reported that there was a battery failure. When the device was unplugged, it immediately shut down. After replacing the battery, the device was in good working order. There was no patient injury reported.

 
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Brand NameEVITA 4
Type of DeviceVENTILATORS, INTENSIVE CARE
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM 23542
Manufacturer (Section G)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM 23542
MDR Report Key11327676
MDR Text Key232200323
Report Number9611500-2021-00064
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
PMA/PMN NumberK0980642
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Type of Report Initial,Followup
Report Date 04/15/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/15/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number8411740
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/30/2010
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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