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 Insufficient Information (4580)

Event Date 02/10/2021

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 there was a ventilator failure during use.There was no injury reported.

Event Description

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

Manufacturer Narrative

As reported by the biomedical engineer, a v044 entry was logged at the time of event.This entry logged indicates a pressure drop at the rolling diaphragm.Unfortunately, as neither the logfile nor any further information such as a service report was made available for investigation, the reported symptom could not be reproduced, and the exact root cause could not be determined.An auxiliary vacuum pressure is needed to operate the valves that control the ventilation cycles and to keep the ventilator diaphragm in place during piston movement.The system reacts with a safety shutdown of automatic ventilation and a corresponding alarm upon insufficient vacuum pressure.A drop in the vacuum pressure may be caused by a number of conditions and some of them are not related to a device malfunction of persisting nature.For example, if the control tube of the peep valve comes off during interaction with the device, will be recognized by the user and re-attached, this leaves no traces for a following device check.Also in the specific case it was reported that the self-test in follow-up to the event passed without any indications for a device malfunction.Dräger finally concludes that the system responded as intended upon a deviation in the auxiliary functions - ventilation was shut down to prevent from damages to the system and, the user was alerted to this condition by means of a corresponding alarm.Manual ventilation remains available.

• 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: 11484800
• MDR Text Key: 246299390
• Report Number: 9611500-2021-00108
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675041474
• UDI-Public: (01)04048675041474(11)160322(17)160817(93)8606000-80
• 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: 05/04/2021

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?: No
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 03/15/2021
• Supplement Dates Manufacturer Received: 04/09/2021
• Supplement Dates FDA Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1