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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA FABIUS GS PREMIUM ANESTHESIA UNITS

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DRÄGERWERK AG & CO. KGAA FABIUS GS PREMIUM ANESTHESIA UNITS Back to Search Results
Catalog Number 8607000
Device Problem Defective Component (2292)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/01/2018
Event Type  malfunction  
Manufacturer Narrative
The investigation has just started; results will be provided in a follow up report.
 
Event Description
It was reported that a ventilator failure was displayed during use and only manual bag ventilation was possible. There was no injury reported.
 
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Brand NameFABIUS GS PREMIUM
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 Key8154286
MDR Text Key130329025
Report Number9611500-2018-00392
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011404
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 12/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/01/2000
Device Catalogue Number8607000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/30/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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