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U.S. Department of Health and Human Services

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

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DRÄGERWERK AG & CO. KGAA FABIUS MRI ANESTHESIA UNITS Back to Search Results
Catalog Number 8607300
Device Problems Gas Output Problem (1266); Loss of Threshold (1633); Failure to Deliver (2338)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/16/2020
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 the device posted a ventilator failure during use. There was no injury reported.
 
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Brand NameFABIUS MRI
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 Key10319007
MDR Text Key200437378
Report Number9611500-2020-00259
Device Sequence Number1
Product Code BSZ
UDI-Device Identifier04048675041498
UDI-Public(01)04048675041498(11)160909(17)170228(93)8607300-42
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072884
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 06/23/2020,08/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number8607300
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Report to Manufacturer06/23/2020
Date Manufacturer Received08/12/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/30/2016
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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