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

Catalog Number 8606000

Device Problems Intermittent Continuity (1121); Gas Output Problem (1266); Failure to Deliver (2338)

Patient Problem Insufficient Information (4580)

Event Date 01/09/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the device posted a vent fail alarm about 1 hour after start of the surgical procedure and shut down automatic ventilation.Rebooting the device could reportedly not remove the error condition whereupon the users decided to move the patient to another or.

Manufacturer Narrative

An on-site investigation of device and log file has confirmed the user's report of unexpected shut-down of automatic ventilation during use.According to the log entries, the supervisor function of the device detected a wrong motor position and forced a shutdown of automatic ventilation.The shut-down was accompanied by a corresponding alarm.The ventilator unit has been replaced; the device passed all consecutive tests and was returned to use.Evaluation of earlier reported similar events revealed that wear-and-tear related abrasion of the collector disc had resulted in development of positions where the motor does not provide mechanic power due to contact interrupts to the carbon brushes; speed fluctuations will be the consequence.The speed fluctuations result in a deviation between measured and expected piston position.The piston hub defines the applied tidal volume and thus, to prevent from potentially hazardous output and/or from damages to the ventilator unit, the system is designed to shut down automatic ventilation and to alert the user to this condition by means of a corresponding alarm.The device design allows manual ventilation with the built-in breathing bag including gas dosage event in switch-off state - this allows at least the bridging of patient support until a replacement device can be introduced.The particular event is considered an isolated case; the motor failed after less than 50% of the estimated life time but the number of such premature failures is inconspicuous.The supplier was informed about the occurrence.

Event Description

It was reported that the device posted a vent fail alarm about 1 hour after start of the surgical procedure and shut down automatic ventilation.Rebooting the device could reportedly not remove the error condition whereupon the users decided to move the patient to another or.

• Brand Name: FABIUS TIRO
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 18631906
• MDR Text Key: 334441344
• Report Number: 9611500-2024-00034
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675041474
• UDI-Public: (01)04048675041474(11)191202(17)200618(93)8606000-88
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8606000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 02/02/2024
• Supplement Dates Manufacturer Received: 03/07/2024
• Supplement Dates FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization