BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUS UPS 2ND GEN 200616

    MDR report key: 9998983 · Received April 24, 2020

    Report

    Report Number
    3010266064-2020-00933
    Event Type
    Malfunction
    Date Received
    April 24, 2020
    Date of Event
    September 12, 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
    SN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE DEVICE WAS INTENDED FOR USE IN TREATMENT AND IT WAS REPORTED AN UPS ERROR, ERROR CODE 20000000000. THE DEVICE WAS NOT MADE AVAILABLE TO THE DESIGNATED COMPLAINT UNIT FOR EVALUATION. THUS, VISUAL AND FUNCTIONAL INSPECTION COULD NOT BE PERFORMED. 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. WE COULD CONFIRM THERE WAS A RELATIONSHIP ESTABLISHED BETWEEN THE REPORTED EVENT AND THE DEVICE. DISCUSSION WITH THE SERVICE DEPARTMENT FOUND THAT THE UPS BATTERY IS SUGGESTED TO BE REPLACED EVERY 2 YEARS AND THAT THE UPS HAD BEEN IN THE FIELD FOR AROUND 4 YEARS AT THE TIME OF THE EVENT OCCURRENCE. THE REPORTER CONFIRMED THAT AFTER THE UPS BATTERY WAS REPLACED THE REPORTED ERROR WAS RESOLVED. THEREFORE, THE MALFUNCTION IS MOST PROBABLY DUE TO RECOMMENDED MAINTENANCE NOT PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED A UPS ERROR INTEGRITY TEST - 20000000000 WAS DISPLAYED / REPLACE UPS - CANNOT RISK THIS FAILING DURING THE NAVIO INSTRUCTIONAL COURSE. NO DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460547 OUS UPS 2ND GEN 200616 ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1