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

Catalog Number 8606000

Device Problems Failure to Deliver (2338); Device Handling Problem (3265)

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

Event Date 11/23/2023

Event Type  malfunction  

Event Description

It was reported that the device had switched off without an alarm during ventilation.The device could be switched on again and was checked.No fault was detected.The patient was ventilated via a ventilation bag during this time.The surgical induction was successfully completed with the same device.No injury reported.

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.

Manufacturer Narrative

The device logbook was analyzed for the day of the reported event, 23.11.2023.No conspicuous entries were found in connection with the reported device failure.It can only be verified that the device was switched on at 7:31 in the morning and again at 9:28.A test run of the device also showed no anomalies.A check of the on/off switch also revealed no results - no deviation from the specification could be identified.As part of the investigation, further case-specific questions were asked, which unfortunately remained unanswered.As no evidence of a device malfunction could be found, it can be assumed that an unintentional activation of the on/off switch caused the device to switch off.The two switch-on processes, as can be seen in the log, confirm this assumption.The first switch-on occurred at the beginning of the procedure in question.Since a switch-off of the device is not recorded in the log, the next entry (after an accidental switch-off) that can be traced in the log is the switch-on sequence.Finally, no device error could be found as cause for the reported symptoms.An user-related cause seems very likely in this case.The analysis of the complaint data does not indicate a systematic accumulation of the symptom described.On the basis of the available investigation results, the case is subsequently assessed as not reportable.

Event Description

It was reported that the device had switched off without an alarm during ventilation.The device could be switched on again and was checked.No fault was detected.The patient was ventilated via a ventilation bag during this time.The surgical induction was successfully completed with the same device.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
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 18289752
• MDR Text Key: 330254022
• Report Number: 9611500-2023-00462
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• 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: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2010
• 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