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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA SAVINA 300 VENTILATORS, INTENSIVE CARE

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DRÄGERWERK AG & CO. KGAA SAVINA 300 VENTILATORS, INTENSIVE CARE Back to Search Results
Catalog Number 8417800
Device Problems Premature Discharge of Battery (1057); Failure to Deliver (2338); Complete Loss of Power (4015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/24/2021
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 the device only works for 8 minutes on battery power. There were no patient health consequences reported.

 
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Brand NameSAVINA 300
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 Key11736361
MDR Text Key250038504
Report Number9611500-2021-00183
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
PMA/PMN NumberK0180779
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 05/28/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/28/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number8417800
Was Device Available For Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/31/2020
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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