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); Electrical Overstress (2924)

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

Event Date 11/24/2022

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 device suddenly posted a ventilator failure alarm and shut down automatic ventilation.There was no detail in the report which would reasonably suggest that patient consequences may have occurred.

Event Description

It was reported that the device suddenly posted a ventilator failure alarm and shut down automatic ventilation.There was no detail in the report which would reasonably suggest that patient consequences may have occurred.

Manufacturer Narrative

The device was serviced by a dräger technician after the reported event.The technician replaced the motor and downloaded the electronic log file.Both log and motor were submitted to dräger for further analyses.Based on the log entries the reported issue could be confirmed and attributed to the motor assembly inlcuding light barrier and encoder disc.The motor was tested and it was found that it was not running smoothly.It was determined that the commutator disc was scratched by the carbon brushes which is a plausible root cause.The fabius detected the restricted movement of the ventilator and reacted as specified for this situation by shutting down automatic ventilation and generating a corresponding alarm.The analysis of the complaint data does not indicate a systematic accumulation of the described symptom.

• 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: 16020467
• MDR Text Key: 306421067
• Report Number: 9611500-2022-00351
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675041474
• UDI-Public: (01)04048675041474(11)191210(17)200624(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: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

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 Catalogue Number: 8606000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 12/01/2023
• Supplement Dates FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: NA.; NA.