BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUS UPS 2ND GEN 200616

    MDR report key: 9994186 · Received April 24, 2020

    Report

    Report Number
    3010266064-2020-00937
    Event Type
    Malfunction
    Date Received
    April 24, 2020
    Date of Event
    October 30, 2018
    Report Date
    April 23, 2020
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    PMA / PMN Number
    K191223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10 H3, H6: THE UPS WAS INTENDED FOR USE IN TREATMENT, WAS RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE UPS WILL NO LONGER POWER ON. DHR REVIEW FOUND THAT NO CONDITIONS WHICH COULD CONTRIBUTE TO THE REPORTED EVENT WERE IDENTIFIED. THIS INFORMATION IS REASONABLY SUGGESTING THAT THE DEVICE MET THE SPECIFICATIONS AT THE DATE WHEN IT WAS RELEASED TO THE DISTRIBUTION. A COMPLAINT HISTORY FOUND SIMILAR REPORTS, THIS ISSUE WILL CONTINUE TO BE MONITORED. BASED ON INVESTIGATION, THE USER ERROR ROOT CAUSE HAS BEEN ELIMINATED AS THE CAUSE OF THE COMPLAINT. WE COULD CONFIRM THERE WAS A RELATIONSHIP ESTABLISHED BETWEEN THE REPORTED EVENT AND THE DEVICE. THE DEVICE WAS RETURNED AND INVESTIGATED FOR INITIAL INVESTIGATION. THE UPS WAS PLUGGED IN WITH A STEP-UP TRANSFORMER AND THE LIGHTS ON THE UPS INDICATED THAT IT DID NOT RECOGNIZE ANY INPUT VOLTAGE. THE UPS WAS POWERED ON AND WHILE IT POWERED ON, IT STILL DID NOT RECOGNIZE ANY INPUT VOLTAGE AND WAS RUNNING ON BATTERY POWER. THEN THE UPS WAS UNPLUGGED AND PLUGGED BACK IN A COUPLE TIMES AND IT WOULD BRIEFLY INDICATE THAT IT WAS RECEIVING POWER AND THEN STOP. THIS IS INDICATIVE OF INTERNAL DAMAGE WITH THE UPS. THIS WAS MOST LIKELY CAUSED BY ELECTRICAL COMPONENT FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPS WILL NO LONGER POWER ON. WHEN THE POWER BUTTON IS PRESSED THE LEDS TURN GREEN FOR A MOMENT THEN THEY SHUT OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459686 OUS UPS 2ND GEN 200616 ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1