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); Device Sensing Problem (2917)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2023

Event Type  malfunction  

Event Description

It was reported that a ventilator failure occurred during use.There was no detail in the report which would reasonably suggest that patient consequences may have occurred.

Manufacturer Narrative

The investigation has just started - results will be provided in a follow-up report.Investigation is on-going.

Manufacturer Narrative

The device was subject to an on-site evaluation by an engineer of the local dräger s&s organization.The reported vent fail during use could be confirmed upon checking the log file.The records stored therein indicate that the supervisor function of the device forced a shutdown of automatic ventilation due to a too high power consumption of the ventilator motor.It could be further determined that this was caused by piston movement against the limit stop because the detection system for the motor position had obviously a problem.After replacement of the connection cable for the light barrier - part of the position detection system - the device was fully functional again and could be returned to use.Due to the low field failure rate, an in-depth investigation of the cable was not considered necessary.Dräger finally concludes that the device responded as designed upon a certain error condition - an autonomous shut-down was forced to protect from serious damages to the ventilator and other components.The user was alerted to this condition by means of a corresponding alarm; manual ventilation including gas dosage remains possible.

Event Description

It was reported that a ventilator failure occurred during use.There was no detail in the report which would reasonably suggest that patient consequences may have occurred.

• 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: 16465886
• MDR Text Key: 310498378
• Report Number: 9611500-2023-00080
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675041474
• UDI-Public: (01)04048675041474(11)191204(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: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2019
• 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