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

Catalog Number	8607300
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the machine rebooted five times during the case and each time booted up to man/spont mode.No injury reported.
Additional Manufacturer Narrative
The device log file was requested but was not provided for investigation.Therefore, a case specific analysis was not possible.The device was tested and inspected on site.All tests passed and the reported symptom could not be reproduced.Finally, based on the available information the root cause for the reported symptom could not be determined.A restart as reported is obvious for the user, since the device is intended to be used under constant supervision only.During a restart, automatic ventilation is interrupted shortly.Manual ventilation via the integrated manual breathing bag remains possible at any time.

• Brand Name: FABIUS MRI
• Common Device Name: 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: 18892676
• Report Number: 9611500-2024-00108
• Device Sequence Number: 17745043
• Product Code: BSZ
• UDI-Device Identifier: 04048675041498
• UDI-Public: (01)04048675041498(11)201119(17)210316(93)8607300-48
• Combination Product (Y/N): N
• PMA/510(K) Number: K072884
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/13/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 8607300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown