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

Catalog Number 8606000

Device Problems Failure to Deliver (2338); No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow up-report.

Event Description

It was reported there was a vent fail whist a patient was connected to the device.There was no patient injury reported.

Manufacturer Narrative

The logfile of the device in question was not available for investigation.However, based on the transmitted information, a ¿v002 - zero position invalid¿ code was found in the log.This entry is generated when it is not possible to zero the ventilator position encoder and points to an issue with the light barrier cable or ventilator assembly.A dräger fse has replaced the light barrier cable and ventilator motor in follow-up of this case.The device was tested, performed according to specifications and could be returned to use.There have been no further problems reported.The replaced material was not made available to the manufacturer for investigation.Hence, a detailed root cause analysis is not possible.The device was in operation for more than 14 years.The motor is designed for a lifetime of ten years at standard operating conditions (5hours/day, 5 days/week).A wear-and-tear related end of life for this component can be considered well-acceptable.Dräger finally concludes that the device responded as designed upon a detected deviation.If it is not possible to adjust the zero point of the position encoder, this may lead to erroneous motor control signals.To prevent from serious damages, the device software shuts down automatic ventilation and triggers a corresponding alarm to alert the user.Manual ventilation remains possible.No patient consequences have occurred.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

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: 9277927
• MDR Text Key: 178329934
• Report Number: 9611500-2019-00368
• 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: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• 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
• Date Manufacturer Received: 11/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1