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

Catalog Number	8607300
Medical Device Problem Codes	Failure to Deliver (2338); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a case that the unit had restarted momentarily and went back to default settings.There was no patient injury reported.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
It was reported during a case that the unit had restarted momentarily and went back to default settings.There was no patient injury reported.
Additional Manufacturer Narrative
The investigation was performed based on the available information.Reportedly the device has been used since the reported event without further problems reported.The electronic log file for the affected date of event were not available.It is assumed that the relevant log entries had already been overwritten by newer ones when the customer reported this case to dräger.Based on what was reported and further information that was gathered during the investigation the root cause could not be determined.Given, that the device has been running without further issues since then, it can¿t be excluded that the reported issue was caused by emc disturbances, since there was a standard network cable connected to the fabius mri during the event.According to the fabius mri instructions for use only fiber optic cables shall be used during operation.Dräger will inform the customer about this requirement.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
• MDR Report Key: 15586001
• Report Number: 9611500-2022-00278
• Device Sequence Number: 20627723
• Product Code: BSZ
• UDI-Device Identifier: 04048675041498
• UDI-Public: (01)04048675041498(11)191106(17)200523(93)8607300-47
• 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,Followup
• Report Date (Section B): 11/22/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 8607300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.; NA.
• Patient Sex: Unknown