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U.S. Department of Health and Human Services

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

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DRÄGERWERK AG & CO. KGAA FABIUS GS PREMIUM ANESTHESA UNITS Back to Search Results
Catalog Number 8607000
Device Problems Unexpected Therapeutic Results (1631); Failure to Deliver (2338); Human-Device Interface Problem (2949)
Patient Problems Death (1802); Hypoxia (1918)
Event Date 03/11/2020
Event Type  Death  
Manufacturer Narrative
The investigation was started; the results will be provided in a follow-up report.
 
Event Description
It was initially reported, that the customer complained because the device did not offer o2 to the patient, leading to hypoxia. Further information was received 2020-03-30: the customer reported that the hypoxia led to bradycardia and to crp. It was further reported that the patient died.
 
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Brand NameFABIUS GS PREMIUM
Type of DeviceANESTHESA 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 Key9902380
MDR Text Key185658069
Report Number9611500-2020-00104
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K011404
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 05/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue Number8607000
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/31/2009
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: 03/31/2020 Patient Sequence Number: 1
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