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

Catalog Number 8606000

Device Problem Decrease in Pressure (1490)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the unit had an error for membrane pressure too low which would not allow the ventilator function.The doctor chose to finish the case with the device having the patient breath spontaneous.There was no injury reported.

Manufacturer Narrative

Based on the log file analysis the entry "membran pressure low" was found which is associated with the reported ventilator failure.This failure code is entered to the log if the membrane vacuum drops below the minimum value for automatic ventilation.The vacuum pressure is necessary to maintain proper function of the ventilator piston diaphragm i.E.To avoid wrinkling during movement.As a precaution in such case the ventilator stops its operation accompanied by an audible and visible "ventilator fail" alarm.As automatic ventilation is not possible anymore the user can switch to manual ventilation as described in the instructions for use.Monitoring is still functional.According to the transmitted service report the failure was fixed by replacing the ventilator lid and installing the 2-year service kit.Post market surveillance data demonstrates that the 2 years maintenance interval for the particular parts is appropriate.

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 23542 ; GM 23542
• MDR Report Key: 8752476
• MDR Text Key: 149930940
• Report Number: 9611500-2019-00194
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: 8606000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1