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

Catalog Number 8604700

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/24/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

Event Description

It was reported the ventilator failed during use.There was no injury reported.

Manufacturer Narrative

The dispatched service engineer could narrow down the root cause for the problem to a worn motor and replaced it.The device passed all tests after the repair exchange and is back in use w/o further problems.The manufacturer has evaluated the log file and found entries which are in relation to the reported ventilator failure: two different error codes can be found in the log; first one is indicating speed deviations and the second one a stalling of the motor, finally.The particular motor has been in operation for more than 12 years.This motor is designed for a lifetime of 10 years at standard operating conditions which the respective unit has lasted.Dräger finally concludes that the device responded as designed upon the malfunction of a wear-and-tear component; it has shut down automatic ventilation when the error occurred to prevent from damages to the ventilator unit and posted a corresponding alarm.Manual ventilation remains possible.Reportedly, no patient consequences have occurred.

Event Description

Please refer to initial mfr.Report #9611500-2019-00044.

• Brand Name: FABIUS GS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 8314510
• MDR Text Key: 135694151
• Report Number: 9611500-2019-00044
• 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: 02/27/2019

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 Expiration Date: 01/01/2000
• Device Catalogue Number: 8604700
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/08/2019
• Initial Date FDA Received: 02/07/2019
• Supplement Dates Manufacturer Received: 01/18/2019
• Supplement Dates FDA Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1