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

Catalog Number 8604700

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Electrical Overstress (2924); No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Results will be provided in a separate follow-up-report.

Event Description

It was reported that there was a ventilator failure during use.There was no injury reported.

Manufacturer Narrative

The dispatched fse has inspected the logs and was able to identify several entries indicating a shut down of the ventilator unit due to motor overcurrent.The entire motor assembly and some other parts have been replaced.The device could be returned to use after proper function has been verified by the defined tests.Log file evaluation made by the manufacturer confirms the expertise that was obtained on-site.The device was in operation for 15 years, it is plausible that high friction forces occurred on the motor, the spindle or the piston due to wear and tear after such long time of use.The repair exchange of the relevant parts was the appropriate measure to rectify the problem.The motor is designed for a lifetime of ten years at standard operating condition - a case where the motor fails after 150% is rated as not unexpected and thus, acceptable.

Event Description

Please refer to initial mfr.Report #9611500-2020-00027.

• Brand Name: FABIUS GS
• Type of Device: ANAESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 9646512
• MDR Text Key: 176952924
• Report Number: 9611500-2020-00027
• 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: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8604700
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1