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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PERSEUS A500 ANESTHESIA UNITS

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DRÄGERWERK AG & CO. KGAA PERSEUS A500 ANESTHESIA UNITS Back to Search Results
Catalog Number MK06000
Device Problems No Device Output (1435); Use of Device Problem (1670); Failure to Deliver (2338); Device Handling Problem (3265)
Patient Problems Death (1802); No Information (3190)
Event Date 11/07/2019
Event Type  Death  
Manufacturer Narrative

The investigation is still on-going. The results will be provided within a follow-up report.

 
Event Description

It was reported that the oxygen supply was unplugged by mistake and that the corresponding posted alarms were silenced and reset. The patient reportedly died.

 
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Brand NamePERSEUS A500
Type of DeviceANESTHESIA UNITS
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 Key9353012
MDR Text Key167312689
Report Number9611500-2019-00390
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
PMA/PMN NumberK133886
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 01/16/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/21/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberMK06000
Was Device Available For Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/30/2019
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: 11/21/2019 Patient Sequence Number: 1
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