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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA INFINITY ACS WORKSTATION CC VENTILATORS, INTENSIVE CARE

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DRÄGERWERK AG & CO. KGAA INFINITY ACS WORKSTATION CC VENTILATORS, INTENSIVE CARE Back to Search Results
Catalog Number 8416400
Device Problems Complete Blockage (1094); Gas Output Problem (1266); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Death (1802)
Event Date 02/04/2021
Event Type  Death  
Manufacturer Narrative

The investigation has been started. Unfortunately the logbook of the affected device have not yet been made available to the manufacturer. Therefore the information for investigation is very limited. Investigation results will be provide in a final report.

 
Event Description

The customer reported that a patient died during the ventilation. The log file showed that exp. Resistance high were frequently recorded.

 
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Brand NameINFINITY ACS WORKSTATION CC
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 Key11320525
MDR Text Key231561209
Report Number9611500-2021-00059
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
PMA/PMN NumberK093633
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 03/30/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/12/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number8416400
Was Device Available For Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 02/12/2021 Patient Sequence Number: 1
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