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 09/02/2020

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.

Event Description

It was reported that the device posted a ventilator failure during use.There was no injury reported.

Manufacturer Narrative

Unfortunately, the log file was not provided by the biomedical technician.However, the logfile reportedly logged entries regarding ¿motor slow¿, ¿motor stall¿ and ¿motor fail¿.In combination with the described symptom, the 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 approx.13 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.Therefore, it was recommended to exchange the motor unit.Dräger finally concludes that the device behaved as specified upon the malfunction of a single component; no patient consequences have been reported.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: 10711200
• MDR Text Key: 212284051
• Report Number: 9611500-2020-00367
• 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: 10/02/2020,11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Date Report to Manufacturer: 10/02/2020
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 11/24/2020
• Supplement Dates FDA Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1