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

Catalog Number 8607300

Device Problems Gas Output Problem (1266); Loss of Threshold (1633); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/16/2020

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.

Manufacturer Narrative

The device was inspected on-site by a dräger service engineer who confirmed the reported issue of ventilator failure and replaced the ventilator motor unit upon the findings of initial log file analysis.The device passed all required tests afterwards and could be returned to use.The replaced motor unit was returned to the manufacturer for an in-depth analysis.Visual examination revealed that the piston was blocked at the lower end.Root cause could be traced back to a damaged incremental encoder sensor - as a result from this error condition the software could not recognize the rotation of the motor anymore and the piston was moved towards the lower end position and remained blocked there.This particular failure mode was never observed before in comparison to more than 100.000 devices sold.If automatic ventilation fails the device posts a corresponding alarm to alert the user.Manual ventilation remains possible then.

Event Description

Please refer to initial mfr.Report #9611500-2020-00259.

• Brand Name: FABIUS MRI
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 10319007
• MDR Text Key: 200437378
• Report Number: 9611500-2020-00259
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675041498
• UDI-Public: (01)04048675041498(11)160909(17)170228(93)8607300-42
• Combination Product (y/n): N
• PMA/PMN Number: K072884
• 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: 06/23/2020,08/21/2020

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: 8607300
• Was Device Available for Evaluation?: No
• Date Report to Manufacturer: 06/23/2020
• Initial Date Manufacturer Received: 06/24/2020
• Initial Date FDA Received: 07/24/2020
• Supplement Dates Manufacturer Received: 08/12/2020
• Supplement Dates FDA Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1