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

Catalog Number 8606000

Device Problems Inaccurate Flow Rate (1249); Unexpected Therapeutic Results (1631); Human-Device Interface Problem (2949); Power Problem (3010)

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

Event Date 12/10/2022

Event Type  malfunction  

Event Description

It was reported that the device powered off during patient use.No patient injury reported.

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

Manufacturer Narrative

Initially, it was reported that the device powered off during use.However, it was additionally reported that something might have bumped the switch physically and the device was switched off.This assumption could be strengthened by the fact that there were no indications for a device malfunction found, neither during check after the event, nor based on the logfile analysis.During an operation check after the event, the battery operated normally and there was no issue found with the power switch after the event.Reportedly, the hospital nurse was able to start the device via the switch.The logfile from the involved fabius trio has been collected and provided for further analysis.The exact time of event has not been provided and therefore, the whole date of event was analyzed.Based on the logfile entries, four occasions could be seen where the device was switched on intentionally by the hospital and a service engineer.There are no entries logged on the date of event indicating that the device was running on battery power nor a ¿ac power fail¿.There is no indication that the device powered off by itself.Finally, based on the fact that the battery was fully charged, the device logfile did not contain any entries related to a power switch failure or battery power, it could be concluded that most likely, the reported symptom was caused by an unintended switch-off, e.G.As it was additionally stated by something coming against the switch that is located on the rear.The ifu explains how to start and end the operation using the fabius tiro device.The on/off switch on the rear of the device is e.G.Used when preparing for storage or transport and therefore shutting the device off completely.The location of the switch, the characteristic of the switch and the fact, that this is the first case of unintentionally switching off the device with the on/off switch on the rear, reduce the likelihood that the described situation occurs by accident.A systematic design issue could be excluded.If known before, the case would have not been assessed reportable.

Event Description

It was reported that the device powered off during patient use.No patient 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: 16016587
• MDR Text Key: 308392277
• Report Number: 9611500-2022-00350
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675041474
• UDI-Public: (01)04048675041474(11)2202-28(93)8606000
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• 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: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2022
• 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