BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 3113696 · Received May 15, 2013

    Report

    Report Number
    1723170-2013-00195
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT WAS PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION. ELECTRICAL EVALUATION OF RELAY RETURNED TO THE MANUFACTURER CONFIRMED THAT THE RELAY WAS SHORTED ON THE OUTPUT, BETWEEN PIN 1 AND 2.

    Description of Event or Problem · 1

    DURING TRAINING, A MEDTRONIC REPRESENTATIVE REPORTED WHEN OPENING THE GENERATOR , THERE WERE SPARKS FROM THE BACK OF THE GENERATOR DOOR. INVESTIGATION REVEALED THAT THE FUSE F3 WAS BLOWN AND THE DRIVE SOLID-STATE RELAY (DRIVE SSR) WAS FOUND TO BE SHORTED ON THE SWITCH AND WERE REPLACED. THEY THEN POWERED THE SYSTEM ON AND TESTED THE DRIVE FUNCTION WHICH WAS WORKING PROPERLY. AGAIN THEY POWERED DOWN THE O-ARM AND AFTER SHUTTING DOWN COMPLETELY THE UNIT HAD THE ABILITY TO MOVE. A FEW DAYS LATER, THE SYSTEM EXHIBITED SIMILAR SPARKS FROM THE BACK OF THE GENERATOR DOOR, WHEN OPENING THE GENERATOR. THE SOURCE OF THE SPARKS WAS THE SHORTED BLACK WIRES RUNNING TO THE F3 FUSE HOLDER. WHILE FUSE F3 REMAINED INTACT, THE RELAY WAS SHORTED AGAIN. THE SSR WAS MEASURED TO CONFIRM THE SAME MEASUREMENT AS WITH THE PREVIOUS SSR. THE FSE PRESSED THE "E-STOP" BUTTON TO CONFIRM FUNCTIONALITY, AND THE SYSTEM STILL HAD THE ABILITY TO DRIVE EVEN AFTER TURNING THE POWER OFF. THE DRIVE SSR HAS BEEN REPLACED AND THE SYSTEM IS NOW FUNCTIONING PROPERLY. THIS EVENT WAS REPORTED ON A TRAINING UNIT AND NOT IN THE OPERATING ROOM. NO PATIENT WAS PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214767 O-ARM 1000 IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC. (LITTLETON) BI-700-00027-120

    Patients

    Seq Age Sex Outcome Treatment
    1