BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 19882714 · Received August 1, 2024

    Report

    Report Number
    3006544299-2024-00585
    Event Type
    Malfunction
    Date Received
    August 1, 2024
    Date of Event
    July 17, 2024
    Report Date
    August 1, 2024
    Manufacturer
    SANMINA -SCI SYSTEMS
    Product Code
    OWB
    PMA / PMN Number
    K200074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: MULTIPLE ANNEX A CODES WERE CODED FOR THIS EVENT. A090501 WAS CODED FOR THE SYSTEM NOT SHOOTING EITHER 2D OR 3D. A1102 WAS CODED FOR THE ERROR MESSAGE. H3, H6: NO PRODUCTS WERE RECEIVED BY THE MANUFACTURER FOR ANALYSIS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT DURING A CASE, THE SYSTEM ATTEMPTED A SPIN BUT GOT AN ERROR MESSAGE STATING "X-RAY DISABLED". AFTER REBOOTING, THE SYSTEM ERROR OCCURRED AGAIN, AND WOULD STILL NOT SHOOT EITHER 2D OR 3D. THE USE OF MEDTRONIC IMAGING WAS ABORTED. DELAY IN SURGERY AND PATIENT IMPACT WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1978309 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SANMINA -SCI SYSTEMS BI70002000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown