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

Catalog Number 4117110

Device Problems Device Reprocessing Problem (1091); Gas Output Problem (1266); Failure to Deliver (2338); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

Event Description

It was reported there was a ventilator failure during a case.There was no injury reported.

Event Description

Please refer to initial mfr.Report.

Manufacturer Narrative

The concerned anesthesia workstation is 17 years old and is being maintained by the user facility on own behalf and responsibility.The log file was evaluated by the manufacturer and indicates the following: there are frequent error entries of type vent pressure very negative.Such record is being generated when the ventilator piston moves down to take in fresh gas and lack of fresh gas is resulting in a negative pressure during piston movement.To compensate the fresh gas deficit the ventilator is equipped with an emergency air intake valve that opens at a certain level of negative pressure.When this valve is sticking the ventilator forces an emergency shut down to prevent from serious damages to the system.This is exactly what happened during the course of event - a vent fail condition is logged for the period in question which confirms the reported observation.A corresponding alarm was posted; manual ventilation remains still possible.It is seen likely that the cleaning recommendations laid down in the ifu were not followed which resulted in sticking of the valve.Dräger finally concludes that the malfunction was not related to a technical component failure but to improper care and maintenance.The workstation responded as designed to this condition.Thus, the issue does not incorporate a previously unidentified or falsely assessed risk.

• 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: 9122472
• MDR Text Key: 186759406
• Report Number: 9611500-2019-00288
• 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: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: 4117110
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/26/2019
• Supplement Dates Manufacturer Received: 10/22/2019
• Supplement Dates FDA Received: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1