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

Catalog Number 8604700

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Improper Flow or Infusion (2954); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2020

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 a ventilator failure occurred during use; no patient consequences have been reported.

Event Description

It was reported that a ventilator failure occurred during use; no patient consequences have been reported.

Manufacturer Narrative

The local service organization has examined the device on-site.The reported issue could be confirmed and traced back to a malfunction of the vacuum pump.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.When the vacuum pump cannot build-up the necessary pressure this can lead to significant damages to the ventilator unit and thus, the system reacts with a shutdown of automatic ventilation and generation of a corresponding alarm.Manual ventilation with the built-in breathing bag remains possible, fio2 measurement is still functional as well.The device is back in use after replacement of the vacuum pump and after having passed all consecutive tests that were performed to confirm proper operation.The field failure rate of the vacuum pump is stable on low level.

• Brand Name: FABIUS GS
• Type of Device: ANESTHESIA UNIT
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 10873801
• MDR Text Key: 217681971
• Report Number: 9611500-2020-00426
• 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: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• 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: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.; NA.