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

Catalog Number 8604700

Device Problems Gas Output Problem (1266); Failure to Sense (1559); Failure to Deliver (2338)

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

Event Date 11/04/2021

Event Type  malfunction  

Event Description

It was reported that during a case the unit displayed an expiratory port leakage alarm and then a vent failure.There was no patient injury reported.

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 an expiratory port leakage alarm and then a vent failure.There was no patient injury reported.

Manufacturer Narrative

As the device log file could not be downloaded pictures of the service log were provided for investigation.Based on these records it was found that repeatedly an expiratory flow of more than 15ml was measured during the inspiration.Automatic ventilation is not restricted by this failure and is continued.Additionally, repeated events were logged that automatic ventilation was selected but could not be started due to a not calibrated peep/pmax valve.This failure is accompanied by a "ventilator fail" alarm.Finally, the reported symptoms could be comprehended based on the log entries.A possible root cause for the detected failure conditions can be an issue with the electronic peep valve placed inside the control box or the mechanical peep valve placed inside the compact breathing system.Reportedly, the electronic peep valve was replaced on-site and the fabius was tested successfully according to draeger specification, afterwards.Unfortunately, the electronic peep-valve was not provided for investigation so that a detailed root cause analysis could not be performed.Replacement of the electronic peep-valve has solved the reported issue and no further issues were reported since then.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 GS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 12907064
• MDR Text Key: 282902239
• Report Number: 9611500-2021-00485
• 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: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1