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

Catalog Number	8607300
Medical Device Problem Codes	Gas Output Problem (1266); Loss of Threshold (1633); Failure to Deliver (2338)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
It was reported that the device posted a ventilator failure during use.There was no injury reported.
Additional 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 or Problem Description
Please refer to initial mfr.Report #9611500-2020-00259.

• Brand Name: FABIUS MRI
• Common Device Name: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 10319007
• Report Number: 9611500-2020-00259
• Device Sequence Number: 3083996
• Product Code: BSZ
• UDI-Device Identifier: 04048675041498
• UDI-Public: (01)04048675041498(11)160909(17)170228(93)8607300-42
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K072884
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2020
• Report Date (Section F): 06/23/2020

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
• Operator of Device: Health Professional
• Device Catalogue Number: 8607300
• Was Device Available for Evaluation?: No
• Date Report to Manufacturer: 06/23/2020
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1