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

Catalog Number 8607000

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/03/2021

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 that during a case the unit displayed a ventilator failure.There was no patient injury.

Event Description

It was reported that during a case the unit displayed a ventilator failure.There was no patient injury.

Manufacturer Narrative

The dispatched fse tested the device and was able to duplicate the reported observation; the workstation was unable to build up the auxiliary vacuum pressure.A new vacuum pump has been installed as well as all parts that are included in the 2 years preventive maintenance kit (upper and lower piston diaphragms, seals and o-rings).The device passed all tests and could be returned to use.The auxiliary vacuum pressure is needed to operate the valves in the cosy and to keep the ventilator diaphragms in place during piston movement to avoid wrinkling.If the pump cannot build-up the necessary pressure the device is designed to shut down automatic ventilation to prevent from serious damages to the ventilator unit resulting from a jammed piston diaphragm and to avoid potentially hazardous output because the valves for ventilation control cannot be actuated properly.The shut-down is accompanied by a corresponding vent fail alarm.All parts that could be put in causal connection to a loss of vacuum pressure have been replaced.It was not exactly determined which part indeed caused the leakage in this specific pneumatic circuit but lack of maintenance cannot be ruled out as a contributing factor.

• Brand Name: FABIUS GS PREMIUM
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• MDR Report Key: 12119946
• MDR Text Key: 262462048
• Report Number: 9611500-2021-00290
• 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: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8607000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1