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U.S. Department of Health and Human Services

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

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DRÄGERWERK AG & CO. KGAA EVITA XL VENTILATORS, INTENSIVE CARE Back to Search Results
Catalog Number 8414900
Device Problems Premature Discharge of Battery (1057); Failure to Deliver (2338); Complete Loss of Power (4015); Unexpected Shutdown (4019)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/16/2020
Event Type  Malfunction  
Manufacturer Narrative

The investigation was started but is not yet concluded. Results will be provided in a follow-up report.

 
Event Description

It was reported that the device stopped due to empty batteries. This was unexpected for the user, although it's not clear if the batteries where fully loaded. No patient consequences reported.

 
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Brand NameEVITA XL
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 Key10122142
MDR Text Key194138309
Report Number9611500-2020-00191
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
PMA/PMN NumberK083050
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 06/07/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/05/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number8414900
Was Device Available For Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/31/2001
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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