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

Model Number	8607300
Medical Device Problem Codes	Failure to Deliver (2338); Therapeutic or Diagnostic Output Failure (3023); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still on-going.The results will be provided with a follow-up report.
Event or Problem Description
It was reported the device rebooted during use.There was no patient injury reported.
Event or Problem Description
It was reported the device rebooted during use.There was no patient injury reported.
Additional Manufacturer Narrative
An investigation was performed based on the provided information.As reported the customer used a ribbon cable for connection instead of a fiber optic cable.This can cause artifacts during mr imaging in the mr examination room and malfunctions on the fabius mri.Therefore the ifu contains a warning always to use the fiber optic cable - approved by dräger - for data transfer to avoid impaired imaging, do not use wired rs232 cables.A siemens service representative that was on-site and the user indicated the issue themself and solved the issue with the use of a fiber optic cable.

• 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: 17180323
• Report Number: 9611500-2023-00223
• Device Sequence Number: 20456912
• Product Code: BSZ
• UDI-Device Identifier: 04048675041498
• UDI-Public: (01)04048675041498(11)221214(17)230419(93)8607300-51
• 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): 08/11/2023

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 Model Number: 8607300
• 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: 05/23/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2022
• 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