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

Model Number 8606000

Device Problems Degraded (1153); Failure to Deliver (2338); No Pressure (2994)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing; results will be provide in a follow-up report.

Event Description

It was reported that a ventilator failure occurred during use.As per report, the users were bridging patient support in manual ventilation mode until a replacement device was available.No patient consequences were resulting from the event.

Manufacturer Narrative

The device was subject to an on-site evaluation by an engineer of the local dräger s&s organization.Log file evaluation revealed the supervisor software had detected two consecutive encoder check errors (wrong motor position) during the concerned procedure and forced a shut-down of automatic ventilation which was accompanied by a corresponding alarm.The device was further used in manual ventilation mode then until a replacement device was made available.An in-depth evaluation of the replaced motor unit was not considered necessary - 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.As confirmed for the particular case, manual ventilation and the monitoring functions remain available to the full extent.Dräger finally concludes that the device behaved as specified upon the malfunction of a single component after 10 years of use; no patient consequences have been reported.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.The entire motor assembly was replaced, the device passed all consecutive tests and could be returned to use.

Event Description

It was reported that a ventilator failure occurred during use.As per report, the users were bridging patient support in manual ventilation mode until a replacement device was available.No patient consequences were resulting from the event.

• Brand Name: FABIUS TIRO
• Type of Device: ANESTHESIA UNIT
• 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: 18363921
• MDR Text Key: 331329651
• Report Number: 9611500-2023-00501
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675041474
• UDI-Public: (01)04048675041474(11)141212(93)8606000-76
• 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: 07/17/2024

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 Model Number: 8606000
• Device Catalogue Number: 8606000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 06/06/2024
• Supplement Dates FDA Received: 07/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2014
• 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