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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Information (3190)
Event Date 04/04/2018
Event Type  Injury  
Manufacturer Narrative

The investigation has just started - results will be provided in a follow-up report.

 
Event Description

It was reported that a patient suffered from cardiac arrest when being transferred from one anesthesia machine used for induction to the second one which was intended to be used for surgery. The users alleged no device malfunction. The case happened in (b)(6) 2018 already but draeger was not made aware before (b)(6) 2018. Patient outcome could not be clarified at the date of reporting.

 
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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 Contact
sonja hillmer
moislinger allee 53-55
lübeck 23542
GM   23542
4518822868
MDR Report Key8168492
MDR Text Key130462085
Report Number9611500-2018-00400
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK133886
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial,Followup
Report Date 01/25/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/17/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/01/2000
Device Catalogue NumberMK06000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/24/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured11/30/2015
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: 12/17/2018 Patient Sequence Number: 1
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