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

Catalog Number 8607000

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 09/20/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started, results will be provided in a follow-up report.H3 other text: on-going.

Event Description

It was reported that during use the device failed with a ventilator failure.No injury reported.

Manufacturer Narrative

The log was analyzed for the reported date and time of the event.An entry was found indicating that due to an uncalibrated peep/pmax valve automatic ventilation could not be started.In this case the a "ventilator failure" alarm will be posted as initially reported.Manual ventilation is still possible.The device was inspected on-site and the reported symptom could be verified.The peep valve assembly was identified as root cause and was replaced in consequence.Afterwards, the device was tested and confirmed to be operationg per manufacturer's specification.The device has reacted on the detected situation as specified by not allowing to start an automatic ventilation sequence accompanied by a corresponding alarm.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.Based on the investigation results, the case was reassessed and categorised as non-reportable as for the current case automatic ventilation could not be started and consequently no peep drop is possible.

Event Description

It was reported that during use the device failed with a ventilator failure.No injury reported.

• Brand Name: FABIUS GS PREMIUM
• 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
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 17911224
• MDR Text Key: 325341339
• Report Number: 9611500-2023-00359
• 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: 11/22/2023

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 Catalogue Number: 8607000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 10/11/2023
• Supplement Dates Manufacturer Received: 11/20/2023
• Supplement Dates FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2016
• 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