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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA FABIUS GS; ANESTHESIA UNITS
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DRÄGERWERK AG & CO. KGAA FABIUS GS; ANESTHESIA UNITS Back to Search Results
Catalog Number 8607000
Device Problems Intermittent Continuity (1121); Gas Output Problem (1266); Failure to Deliver (2338); No Pressure (2994)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/26/2020
Event Type  malfunction  
Manufacturer Narrative
The investigation is still on-going.The results will be provided with a follow-up report.
 
Event Description
It was reported that the patient was ventilated in controlled volume mode when suddenly the ventilator stopped.After several attempts to restart it, it continued to fail.The surgical procedure was continued in manual mode.No patient injury reported.
 
Manufacturer Narrative
The device was subject to on-site evaluation whereby it could be confirmed that the ventilator was not operable.The log entries demonstrate that the supervisor function of the software forced a shutdown of automatic ventilation after having detected a stalled motor.This is a safety measure to prevent from mechanical damages to the ventilator unit.The user is alerted to the shutdown of automatic ventilation by a corresponding alarm; manual ventilation remains possible and, the other device functions like gas dosage and monitoring remain unaffected.The device was in operation for 12 years now; it is seen likely that beginning wear and tear at the collector disc of the ventilator motor has led to intermittent losses of electrical contact between collector and the carbon brushes which resulted in speed fluctuations and finally to a stalling of the motor.Reportedly the user finished the surgical procedure by perfoming manual ventilation with the built-in breathing bag as intended for such error condition; no patient consequences have occurred.The number of similar cases is within the foreseen range of the device's risk management and thus accepted.
 
Event Description
It was reported that the patient was ventilated in controlled volume mode when suddenly the ventilator stopped.After several attempts to restart it, it continued to fail.The surgical procedure was continued in manual mode.No patient injury reported.
 
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Brand Name
FABIUS GS
Type of Device
ANESTHESIA UNITS
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM  23542
MDR Report Key10585493
MDR Text Key208498426
Report Number9611500-2020-00336
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 11/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8607000
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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