BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 19566524 · Received June 19, 2024

    Report

    Report Number
    3006544299-2024-00465
    Event Type
    Malfunction
    Date Received
    June 19, 2024
    Date of Event
    June 10, 2024
    Report Date
    June 19, 2024
    Manufacturer
    SANMINA -SCI SYSTEMS
    Product Code
    OWB
    UDI-DI
    00763000355555
    PMA / PMN Number
    K200074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: MULTIPLE ANNEX A CODES WERE CODED FOR THIS EVENT. A05 WAS CODED FOR THE WHEELS WOULD NOT ENGAGE PROPERLY AND MAKING IT HARD TO DRIVE. A1502 WAS CODED FOR THE SYSTEM NOT DOCKING. A090501 WAS CODED FOR THE SYSTEM NOT EXPOSING. H3, H6: THE SYSTEM WAS SERVICED IN THE FIELD AND NO FAILURE WAS FOUND. 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. 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 OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE UNIT WAS "NOT FUNCTIONING AS INTENDED". THE SITE CLAIMED THAT THE SYSTEM WOULD NOT EXPOSE, AND WAS UNABLE TO DOCK. AT TIMES, THE WHEELS WOULD NOT ENGAGE PROPERLY, MAKING IT HARD TO DRIVE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597167 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SANMINA -SCI SYSTEMS BI70002000 00763000355555

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown