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

Catalog Number 8604700

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.

Event Description

It was reported during use that the unit displayed a vent failure.The patient was bagged, and there was no injury reported.

Event Description

It was reported during use that the unit displayed a vent failure.The patient was bagged and there was no injury reported.

Manufacturer Narrative

A dräger service engineer has examined the device on-site and could confirm the reported ventilator failure upon log file review.It was traced back to a drop in the auxiliary vacuum pressure.The auxiliary vacuum pressure is needed to actuate the valves that control the ventilation cycles and to keep the ventilator diaphragm in place during piston movement.Wrinkling of the piston diaphragm can cause severe damages to the ventilator unit if not avoided.The system effect of a leak in the pneumatic circuit of auxiliary vacuum is that the pump cannot build-up the necessary pressure upon which the system reacts with a shutdown of automatic ventilation and generation of a corresponding alarm; manual ventilation remains possible.Some of the parts of the vacuum circuit are included in the annual service kit.The service engineer has replaced these as well as some housing parts.This has put back the 15yo device into fully operable condition, confirmed by consecutive testing.Dräger finally concludes that the device behaved as specified upon an error condition inone of the subsystems.The device is back in use after repair.No patient consequences have been reported for the particular event.

• 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: 10695990
• MDR Text Key: 211854635
• Report Number: 9611500-2020-00361
• 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: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• 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: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1