BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUS UPS 2ND GEN 200616

    MDR report key: 9994214 · Received April 24, 2020

    Report

    Report Number
    3010266064-2020-01146
    Event Type
    Malfunction
    Date Received
    April 24, 2020
    Date of Event
    January 14, 2019
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10 H3, H6: THE DEVICE WAS INTENDED FOR USE IN TREATMENT AND IT WAS REPORTED THAT THERE WAS AN UPS COMMUNICATION FAILURE, NAVIO WOULD NOT START UP. THE DEVICE WAS NOT MADE AVAILABLE TO THE DESIGNATED COMPLAINT UNIT FOR INVESTIGATION. THUS, VISUAL 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 REPORTER FOUND THAT AFTER PERFORMING THE TROUBLESHOOTING STEPS RECOMMENDED BY THE SERVICE TEAM, THE ISSUE WAS FIXED AND THE SYSTEM WAS ABLE TO START UP WITHOUT A UPS COMMUNICATION FAILURE. THE TROUBLESHOOTING DONE WAS TO POWER DOWN THE SYSTEM, UNPLUG THE NAVIO SYSTEM FROM WALL POWER, TURN ON THE NAVIO SYSTEM ON THE UPS POWER AND ALLOW IT TO BOOT UP, AND THEN PLUG IT BACK IN WHEN IT BOOTS TO THE NAVIO SPLASH SCREEN. THIS IS INDICATIVE OF THE UPS NOT BEING PROPERLY CHARGED ROUTINELY OR THE UPS BATTERY NOT BEING REPLACED EVERY 2 YEARS AS RECOMMENDED. THE MALFUNCTION IS MOST PROBABLY DUE TO RECOMMENDED MAINTENANCE NOT PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NAVIO WAS SHOWING A UPS COMMUNICATION FAILURE, NAVIO WOULD NOT START UP, HAD TO CHANGE TO ANOTHER BACK UP MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460555 OUS UPS 2ND GEN 200616 ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1