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

Catalog Number 8606000

Device Problem Defective Device (2588)

Patient Problem Urinary Retention (2119)

Event Date 07/24/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the last two nights the unit experienced a vent failure.The cases were finished using manual ventilation.There was no injury reported.

Event Description

Please refer to the initial-report.

Manufacturer Narrative

The investigation was performed based on the initially provided information as neither the device log file nor the replaced kollmorgen motor were made available.It was just reported that the logs showed two error entries "motor slow" and "motor stalled" which indicate deviations in the motor's rotation speed.As specified for this situation and as reported the ventilator was stopped accompanied by a corresponding "vent fail" alarm.Manual ventilation is still possible and the patient status can be derived from the readings of the mandatory patient gas monitoring.Root cause can be traced back to the motor as its replacement has solved the reported issue.A more precise analysis which component in detail has caused the issue is not possible as the replaced motor was already discarded by the biomed on-site.As the motor is a wear-and-tear part it is imaginable that after 12 years in operation a single motor component can fail.Finally it can be concluded that the number of similar cases, related to the same root cause (kollmorgen motor), is within the expected range of the respective risk assessment and thus accepted.

• 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: 7854661
• MDR Text Key: 119789967
• Report Number: 9611500-2018-00290
• 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: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• 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: 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1