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

Catalog Number 8604700

Device Problems Failure to Deliver (2338); No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2019

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 stopped working during use.The user immediately manually ventilated the patient and switched to the spare device.There was no patient injury reported.

Event Description

Please refer to initial mfr.Report # 9611500-2019-00428.

Manufacturer Narrative

The responsible technician reportedly checked the device on-site and traced the issue back to the ventilator motor.The entire motor assembly was replaced, consequently.Even though requested, logfiles were not received for detailed root cause analysis.In case the fabius device shuts down automatic ventilation, the device will generate an audible alarm and a visible alarm message "ventilator fail" will be displayed.In this case, automatic ventilation is not possible.The user can switch to manual ventilation as described in the instructions for use.Monitoring is still functional.The motor asm has brushes, ball bearing, commutator disk and a spindle which are affected from aging caused by wearing.The device was in operation for approx.15 years.The motor is designed for a lifetime of ten years at standard operating conditions (5hours/day, 5 days/week).A wear-and-tear related end of life for this component can be considered well-acceptable.The replacement of the affected motor asm by the responsible technician has already solved the problem, no patient consequences have reportedly occurred.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
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 9456061
• MDR Text Key: 186751748
• Report Number: 9611500-2019-00428
• 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: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• 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: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1