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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 Decrease in Pressure (1490); Inaccurate Delivery (2339); Gas Leak (2946)
Patient Problem No Information (3190)
Event Date 12/05/2020
Event Type  Injury  
Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report. Initial log analysis revealed no hint for the potential presence of a device malfunction; a use error can however not be excluded to date. This report is filed in abundance of caution since patient outcome is not clear and, it cannot be excluded that medical intervention was performed.

 
Event Description

It was reported that impairments in ventilation occurred during a surgical procedure. The patient experienced a desaturation; further details are not known to date.

 
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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 Key11019273
MDR Text Key221750300
Report Number9611500-2020-00460
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 01/25/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/16/2020
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 Received01/22/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/31/2015
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: 12/16/2020 Patient Sequence Number: 1
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