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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); Gas Output Problem (1266); Decrease in Pressure (1490); Failure to Deliver (2338); Complete Loss of Power (4015)
Patient Problem Low Oxygen Saturation (2477)
Event Date 01/14/2021
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 "after moving the device in the hospital by battery operation (2 to 3 minutes), the reported device was connected to the outlet and the power lamp was lit, but the battery reduction alarm sounded. The alarm (on the log) was improved once during the connection to the outlet, but the battery reduction alarm rang again. The power was turned off after the alarm sounded in the order of "internal battery less than 30%" and "internal battery less that 10%". " the user switched to manual ventilation and replaced the device with the same model. There was no serious injury 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 Key11300940
MDR Text Key232399764
Report Number9611500-2021-00050
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 03/22/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/09/2021
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 Received03/19/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/31/2016
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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