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

Catalog Number 8606000

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

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

Event Date 04/20/2022

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.

Manufacturer Narrative

The analysis was performed based on the submitted information including the electronic logfile of the device.The reported failure of the ventilator could be confirmed by means of the information stored in the log.The log entries indicate that the vacuum pressure that is required to keep the ventilator diaphragm in place was too low.The fabius reacted as specified for this situation- stopped the automatic ventilation and posted a corresponding alarm.In this case fresh gas delivery (incl.Agent) remains available and the patient can be ventilated using the manual breathing bag.The device was checked on-site by a draeger service technician.A leakage at the lower rolling diaphragm caused by a crease on the lip of the diaphragm was identified as root cause for the reported event.The leakage was removed by fixing the crease.The device was successfully tested afterwards and was returned to clinical use.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

Event Description

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

• 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
• MDR Report Key: 14336330
• MDR Text Key: 297359967
• Report Number: 9611500-2022-00112
• Device Sequence Number: 1
• Product Code: BSZ
• 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: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• 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
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2005
• 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