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

Catalog Number 8606000

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 11/09/2023

Event Type  malfunction  

Event Description

A vent failure mid procedure was reported.No injury reported.

Manufacturer Narrative

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

Event Description

A vent failure mid procedure was reported.No injury reported.

Manufacturer Narrative

The log was analyzed for the reported date of the event.An entry indicated that the system leak test failed due to a leak between fan, tubing, peep valve and bag.Furthermore, it was found that due to an uncalibrated peep valve automatic ventilation could not be started.In this case a "ventilator failure" alarm is posted.Manual ventilation is still possible.The device was inspected on-site.When testing the unit a "ventilator failure" message was posted.Besides this a faulty apl valve was identified which most likely has caused the leak test to fail.The apl valve was replaced with a new one and all sensors were recalibrated.Afterwards, the device was tested and confirmed to be operating per manufacturer's specification.Based on the available investigation results the ventilator failure which reportedly occurred during use could not be confirmed.It could be comprehended that the device was powered on around the reported event time and that automatic ventilation could not be started due to missing peep data.By calibration of all sensors during service activity also the peep valve was recalibrated and solved the issue.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 occurred.

• Brand Name: FABIUS TIRO
• 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: 18214488
• MDR Text Key: 329074992
• Report Number: 9611500-2023-00395
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675041474
• UDI-Public: (01)04048675041474(11)171116(17)180327(93)8606000-85
• Combination Product (y/n): N
• PMA/PMN Number: K042419
• 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: 01/19/2024

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: 8606000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 01/16/2024
• Supplement Dates FDA Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2017
• 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