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

Catalog Number 8606000

Device Problems Intermittent Continuity (1121); Gas Output Problem (1266); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2020

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 during use, the automatic ventilation failed.There was no patient injury reported.

Event Description

It was reported that during use, the automatic ventilation failed.There was no patient injury reported.

Manufacturer Narrative

Unfortunately, neither the electronic device log file nor replaced parts were available for investigation.As reported, the ventilator asm was replaced by 3rd party.No further information could be provided.In case the fabius 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 kollmorgen motor asm, that was installed in the objected device, has been designed for a durability of >10 years (5 hrs/day, 5 days/week, 52 weeks/year, 13000 hours).The involved motor is more than 12 years old (device manufactured in 08/2008).The affected motor asm has already been replaced, 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 TIRO
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 10850019
• MDR Text Key: 216945525
• Report Number: 9611500-2020-00412
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8606000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1