BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIOBE MNS PHILIPS

    MDR report key: 10268322 · Received July 13, 2020

    Report

    Report Number
    3003084417-2020-00218
    Event Type
    Malfunction
    Date Received
    July 13, 2020
    Date of Event
    June 1, 2020
    Report Date
    July 10, 2020
    Manufacturer
    STEREOTAXIS
    Product Code
    NDQ
    PMA / PMN Number
    K192775
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A PATIENT OF UNKNOWN AGE AND GENDER WAS UNDERGOING A VT ABLATION. THE PHYSICIAN HAD ALREADY MAPPED THE LV AND WAS ABLATING THE VENTRICLE. IN THE MIDDLE OF THE PROCEDURE THE PHYSICIAN WAS APPLYING A FIELD THERE WAS A LOUD NOISE THAT SEEMED TO COME FROM MP1 AND THEN THE SYSTEM SHUT OFF ON ITS OWN. TROUBLESHOOTING OCCURRED IMMEDIATELY AT THE SITE, AND THE SYSTEM REMAINED DOWN. AFTER A SHORT PERIOD OF TIME OF TRYING TO BRING THE SYSTEM BACK UP, IT WAS RECOMMENDED THAT THEY HAND CRANK THE MAGNETS AND GO TO A MANUAL APPROACH TO COMPLETE THE ABLATION. TOTAL DELAY TIME WAS APPROXIMATELY 45 MINUTES. TO AVOID REMAPPING OF THE LEFT VENTRICLE, THE PHYSICIAN COMPLETED THE ABLATION MANUALLY AND THE PATIENT REMAINED ON THE TABLE AND THE MAGNETS WERE MOVED TO STOW POSITION. THERE WAS NO INJURY TO THE PATIENT. THERE WAS HOWEVER, SIGNIFICANT DELAY OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726503 NIOBE MNS PHILIPS NIOBE ES NDQ STEREOTAXIS ES PHILIPS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1