• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Consequences Or Impact To Patient (2199)
Event Date 06/23/2020
Event Type  Malfunction  
Manufacturer Narrative

The event dates back to (b)(6) 2020, already. The device was examined by a dräger service technician soon after the event but the hospital did not disclose that time that the shut-down occurred during use on a patient. The technician could verify that operation on battery did not work properly, and traced it back to an outdated battery. The battery was replaced, the device was tested, and is back in use since then without further problems reported to date. The savina is equipped with an internal battery that is intended to cover mains power losses or ensure ongoing ventilation during a patient transport. It is clearly stated in the ifu the internal battery must be checked in regular intervals and must be replaced after 2 years. The particular device involved in the event is 2. 5 years old and was still equipped with the initial battery. One effect of battery ageing typically is that the characteristic discharging curve changes over time, which results in an imprecise runtime forecast. Dräger finally concludes that lack of maintenance was at least a contributing factor in the event.

 
Event Description

It was reported that the device suddenly alarmed for battery depletion and shut down during patient transport despite a 100% charging status was displayed during pre-use check. The device was replaced; no patient consequences have occurred.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11025250
MDR Text Key222417739
Report Number9611500-2020-00462
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
PMA/PMN NumberK003068
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Type of Report Initial
Report Date 12/17/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/17/2020
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 Received12/08/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/28/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-