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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 Consequences Or Impact To Patient (2199)
Event Date 04/13/2020
Event Type  Malfunction  
Manufacturer Narrative

The manufacturer investigation was performed based on the provided information including the log file. The logged entries confirm the reported event. If the savina 300 is not connected to mains power or an external battery, the unit switches to the internal battery with audible alarm and displays the message "internal battery activated". This alarm can be acknowledged, so that only one note with the same message remains. Upon further decrease in capacity (<30%), the device alerts the user by generating the alarm "internal battery low". Before the end of the operating time (<10% remaining capacity) the device alarms with the high priority alarm "internal battery discharged". When fully discharged, the ventilation stops and the device switches off with a power failure alarm with high priority, which remains active for at least 2 minutes. Due to the unusual short timeframe between battery related alarm generation (less than one minute), it is likely that the internal battery was damaged or worn and could only hold a reduced capacity. The savina 300 is equipped with batteries with lead-gel technology. Batteries of this type perform particularly well when used as a backup battery. If these batteries are used in irregular alternating mode, e. G. In intra-clinical transport, the service life is shorter due to technology. A more frequent replacement of the internal battery or the additional use of the external battery is recommended in this case. The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

 
Event Description

It was reported that during use (battery operation), the device alarmed and shut down. No patient consequences have been 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 Key10068753
MDR Text Key191574910
Report Number9611500-2020-00166
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
Report Date 05/19/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/19/2020
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 Received04/21/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/30/2010
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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