BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPS US 200029

    MDR report key: 9994210 · Received April 24, 2020

    Report

    Report Number
    3010266064-2020-01145
    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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE DEVICE WAS INTENDED FOR USE IN TREATMENT AND IT WAS REPORTED THAT THERE WAS AN ERROR MESSAGE STATING A UPS COMMUNICATION FAILURE. 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. THE UPS BATTERY WAS REPLACED BY THE SERVICE TEAM AND THE ERROR WAS FIXED. IT IS SUGGESTED THAT THE UPS BATTERY IS REPLACED EVERY 2 YEARS BECAUSE OF WEAR FROM REGULAR USE. IT WAS REPORTED THAT AFTER REPLACING THE BATTERY, THERE HAVE NOT BEEN ANY FURTHER ISSUES. THE MALFUNCTION IS MOST PROBABLY DUE TO RECOMMENDED MAINTENANCE NOT PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SALES REP STARTED UP THE CART AS NORMAL AND WAS ABLE TO INPUT INFORMATION AND BEGIN A CASE. ABOUT 15 MINUTES AFTER BEGINNING I GOT AN ERROR MESSAGE STATING UPS COMMUNICATION FAILURE. ONLY OPTION WAS TO DISMISS, WHICH IN TURN FORCED ME TO EXIT THE CASE AND RETURN TO THE CASE INPUT SCREEN. SALES TRIED RESUMING THE CASE BUT IMMEDIATELY GOT THE SAME ERROR MESSAGE. SALES REP COMPLETELY SHUT DOWN THE MACHINE AND RESTARTED. THE SAME THING HAPPENED AFTER EVERY ATTEMPT. EVERY TIME SALES REP RESTARTED, THE ERROR MESSAGE CAME UP SOONER THAN THE TIME BEFORE. HE CHECKED TO MAKE SURE EVERYTHING WAS PLUGGED IN SECURELY IN THE BACK OF THE MACHINE AND ALL CORDS WERE CONNECTED SECURELY. NO DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460278 UPS US 200029 ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1