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

Catalog Number 8607000

Device Problems Intermittent Continuity (1121); Gas Output Problem (1266); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.The results will be provided within a follow-up report.

Event Description

It was reported during a case that the unit alarmed "vent failure." the patient was bagged for the remaining 5 minutes of the case.There was no patient injury reported.

Event Description

Please refer to initial mfr.Report #9611500-2020-00086.

Manufacturer Narrative

The involved device is not under a service contract and thus, the hospital's biomed was seeking dräger's assistance.After initial log review the entire motor assembly was replaced which has put back the device into fully operable condition.The replaced motor was returned to the manufacturer and it's evaluation confirms the results obtained from initial log file analysis.Checking the motor in a specific test stand revealed that wear and tear at the collector disc of the motor led to partly disrupted electrical contact to the carbon brushes which results in fluctuations in rotating speed.The supervisor function monitors the motor speed continuously and compares the expected piston position with the one derived by the encoder check.If deviations are detected the device will force a shutdown of automatic ventilation to prevent from damages to the ventilator unit.This is accompanied by a corresponding alarm; manual ventilation as well as the monitoring functions remain available.No patient consequences have occurred and dräger finally concludes that the primus workstation responded as designed upon the malfunction of a single component that became worn after approx.Twelve years of operation.In comparison to the specified lifetime of ten years this can be considered acceptable.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• Brand Name: FABIUS GS PREMIUM
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 9864285
• MDR Text Key: 184424756
• Report Number: 9611500-2020-00086
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K011404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8607000
• Was Device Available for Evaluation?: No
• Device Age: YR
• Date Manufacturer Received: 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1