BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIOBE MNS PHILIPS

    MDR report key: 10352938 · Received July 31, 2020

    Report

    Report Number
    3003084417-2020-00263
    Event Type
    Malfunction
    Date Received
    July 31, 2020
    Date of Event
    July 16, 2020
    Report Date
    July 16, 2020
    Manufacturer
    STEREOTAXIS
    Product Code
    NDQ
    PMA / PMN Number
    K060967
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2020, A PATIENT WAS UNDERGOING AN ABLATION PROCEDURE. THE PHYSICIAN WAS APPLYING VECTORS, THEN PAUSED THE PROCEDURE TO ALLOW ANESTHESIA TO INTUBATE THE PATIENT. DURING INTUBATION, THE VECTOR STARTING MOVING ON ITS OWN. AFTER ABOUT 10 SECONDS, THE MOTIONS STOPPED. A REVIEW OF THE PROCEDURE LOGS DETERMINED THAT THE KEY GOT STUCK BETWEEN 10:19:29.924 AND 10:19:41.046, OR ~12 SECONDS WHICH EQUATES TO PRESSING THE BUTTON 340 TIMES. THIS WOULD NOT HAVE TRIGGERED THE 30 SECOND WARNING OF A KEY BEING PRESSED DOWN. 2 MINUTES LATER, NORMAL VECTOR MOVEMENTS WERE RECORDED. THERE WAS NO INJURY TO THE PATIENT. THIS INCIDENT GIVES THE APPEARANCE THAT AN OBJECT WAS SET ON THE LEFT ARROW KEY FOR A SHORT PERIOD OF TIME, AND THEN WAS REMOVED, HOWEVER THE PHYSICIAN WAS NOT AWARE OF ANYTHING BEING SET ON THE KEYPAD TO CAUSE THIS MOTION. PER THE LOCAL REPRESENTATIVE, SOMETIMES THE KEYPAD IS PLACED BEHIND THE SCREEN AND LIKELY WAS NOT SEEN BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812717 NIOBE MNS PHILIPS NIOBE ES NDQ STEREOTAXIS ES PHILIPS

    Patients

    Seq Age Sex Outcome Treatment
    1