BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUS UPS 1ST GEN 200010

    MDR report key: 9998986 · Received April 24, 2020

    Report

    Report Number
    3010266064-2020-00935
    Event Type
    Malfunction
    Date Received
    April 24, 2020
    Date of Event
    September 28, 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
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10 H3, H6: THE UPS WAS INTENDED FOR USE IN TREATMENT, AND WAS RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE SYSTEM DOES NOT START WHEN THE SWITCH IS PRESSED ON THE UPS. 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. 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 NAVIO SYSTEM RETURNED BACK FROM CUSTOMER, UPON INSPECTION THE SYSTEM DOES NOT START WHEN SWITCH IS PRESSED ON UPS. NO SURGERY INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460818 OUS UPS 1ST GEN 200010 ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1