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

Catalog Number 8607000

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Electrical Overstress (2924)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2021

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 part way through the case the unit came back up with a ventilator failure.The patient was bagged and the unit was swapped out.No injury reported.

Event Description

It was reported that part way through the case the unit came back up with a ventilator failure.The patient was bagged and the unit was swapped out.No injury reported.

Manufacturer Narrative

The investigation was performed based on a screenshot of the error code entries as the device log could not be downloaded by the biomed.An evaluation of the log extract shows that during the case in question the supervisor function of the software detected a stalled motor.In this case a shutdown of automatic ventilation is forced.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.According to the biomed the problem was solved by removing and reseating of the motor.Therefore it can be assumed that high friction at the spindle or the piston/diaphragm has caused the reported symptom.After the repair action the device was returned to use without further problems reported.Dräger finally concludes that the device behaved as specified upon the detected malfunction; 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: 11371414
• MDR Text Key: 245315282
• Report Number: 9611500-2021-00083
• 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: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• 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?: Yes
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1