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

Catalog Number 8606000

Device Problems Use of Device Problem (1670); Failure to Deliver (2338)

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

Event Date 07/21/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation has been started; results will be provided within the follow-up report.

Event Description

It was reported that the device failed during use.There was no injury reported.

Manufacturer Narrative

As further clarified with the user in the course of investigation, it was confirmed that the case in question did not occur on 2022-07-21 but 2022-07-15.Based on the provided logfile, no entries were found that are related to the reported device failure.Finally, as the reported event could not be comprehended, the root cause of the reported symptom could not be determined.On the basis of the information available, the case is classified as non-serious incident and if investigation results were known before, the case would not have been rated reportable.In general, if automatic ventilation stopped, the device would post a corresponding alarm to inform the user about the situation.In any case, manual ventilation and spontaneous breathing is still be possible in switched-off state.

Event Description

It was reported that the device failed during use.There was no injury reported.

• 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
• MDR Report Key: 15468835
• MDR Text Key: 306089296
• Report Number: 9611500-2022-00242
• Device Sequence Number: 1
• Product Code: BSZ
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/20/2022

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: 09/07/2022
• Initial Date FDA Received: 09/22/2022
• Supplement Dates Manufacturer Received: 12/07/2022
• Supplement Dates FDA Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2017
• 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