BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPS US 200029

    MDR report key: 9994207 · Received April 24, 2020

    Report

    Report Number
    3010266064-2020-01147
    Event Type
    Malfunction
    Date Received
    April 24, 2020
    Date of Event
    February 11, 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

    H10 H3, H6: THE DEVICE WAS NOT MADE AVAILABLE TO THE DESIGNATED COMPLAINT UNIT FOR EVALUATION. THUS, VISUAL INSPECTION COULD NOT BE PERFORMED. DISCUSSION WITH THE SERVICE MANAGER FOUND THAT WHEN HE WAS SERVICING THE SYSTEM DURING PREVENTATIVE MAINTENANCE VISIT, THE UPS HAD BEEN CHARGING FOR A COUPLE OF DAYS AND THAT THE SYSTEM WAS ABLE TO BOOT. THE UPS BATTERY WAS REPLACED DURING PREVENTATIVE MAINTENANCE BECAUSE IT IS SUGGESTED THAT IT BE REPLACED EVERY 2 YEARS. AT THE TIME OF THE REPORTED EVENT ON (B)(6) 2019, THE MACHINE HAD GONE UNUSED FOR 2 MONTHS (THE PERVIOUS USE WAS (B)(6) 2018 ACCORDING TO THE FIELD REPORT). SINCE THE SYSTEM WAS UNUSED FOR SO LONG, IT NEEDED MORE THAN THE REPORTED 20 MINUTES OF CHARGING BEFORE USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE TWO SEPARATE ERRORS, BUT WE THINK BOTH OCCURRED BECAUSE THE MACHINE HAS GONE UNUSED SINCE (B)(6) 2018. THE FIRST PROBLEM RELATED TO THE INTERNAL BATTERY OF THE CPU. BECAUSE IT HAD DIED, I HAD TO RESET THE BIOS AND DATE SETTINGS BEFORE BOOTING THE SYSTEM. UPON SOLVING THAT ISSUE, I GOT ERRCODE=2000000000000 UPS BACK-UP BATTER IS NOT WORKING PROPERLY. THE LED INDICATOR ON THE FAR RIGHT, IN THE FRONT PANEL OF THE NAVIO CART WAS RED. WHEN I TALKED TO (B)(6), HE SAID I JUST HAD TO WAIT FOR IT TO GET SOME CHARGE. HOWEVER, AFTER MULTIPLE REBOOTS AND ABOUT 20 MINUTES OF CHARGING, THE LED INDICATOR REMAINED RED AND THE ERROR WOULD SHOW UP WHEN THE SYSTEM BOOTED. CASE HAD TO BE CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460276 UPS US 200029 ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1