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

Catalog Number 8606000

Device Problem No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that at the beginning of the operation the device worked normally.But later on the device reportedly has posted an alarm and displayed "could not work normally." the user switched to manual ventilation.No injury reported.

Manufacturer Narrative

The investigation was performed based on the available device log file.As the exact date of the event could not be provided anymore the complete log file was reviewed finding the error code v045 "membrane pressure high" which is connected to the reported symptom.This event is logged when the membrane vacuum exceeds the maximum value of ¿ 250mbar for automatic ventilation.The vacuum pressure is required to keep the ventilator membrane in place during piston movement.If the device detects a significant deviation between measured value and target value, the ventilator stops working as a precautionary measure and shuts down the automatic ventilation accompanied by an audible alarm and a visible alarm message "ventilator fail".Switching to manual ventilation is possible and monitoring is still functional.Additional information was received that the device was not maintained by the hospital within the required service interval and that the filter of the vacuum pump was found to be blocked.As after cleaning of the filter the device worked normally a blocked filter of the vacuum pump was determined to be root cause of the reported problem.The affected fabius is 10 years old and the respective filter is part of the yearly service procedure.The fabius has reacted as specified for the detected situation and has posted appropriate alarms to inform the user.

Event Description

Please refer to the initial-report.

• Brand Name: FABIUS TIRO
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• MDR Report Key: 9334310
• MDR Text Key: 178148972
• Report Number: 9611500-2019-00387
• 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
• Type of Report: Initial,Followup
• Report Date: 12/20/2019

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 Catalogue Number: 8606000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/18/2019
• Supplement Dates Manufacturer Received: 11/26/2019
• Supplement Dates FDA Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.; NA.