BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUS UPS 2ND GEN 200616

    MDR report key: 9994180 · Received April 24, 2020

    Report

    Report Number
    3010266064-2020-00936
    Event Type
    Malfunction
    Date Received
    April 24, 2020
    Date of Event
    October 3, 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
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE UPS WAS INTENDED FOR USE IN TREATMENT, AND WAS RETURNED FOR INVESTIGATION. THERE WAS NO SERIAL/LOT NUMBER PROVIDED FOR DHR REVIEW SO IT COULD NOT BE CONCLUDED IF THE DEVICE MET THE MANUFACTURING SPECIFICATIONS. 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 RETURNED 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 THE FUSES IN THE SILVER BOX WOULD BLOW EVEN AFTER REPLACING THEM. REPLACED THE UPS AND THAT FIXED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459681 OUS UPS 2ND GEN 200616 ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1