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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 8417801
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 04/12/2021
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 switched off itself during transport from the cardiac catheter laboratory (translation of: (b)(6)) to the icu. The device had been connected to oxygen and power source of the supply unit before. The procedure at the cardiac catheter laboratory lasted for 60 minutes. 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 Key11783286
MDR Text Key251734755
Report Number9611500-2021-00198
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
PMA/PMN NumberK180779
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 07/01/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/06/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number8417801
Was Device Available For Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/12/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/28/2019
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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