BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUS UPS 1ST GEN 200010

    MDR report key: 9998985 · Received April 24, 2020

    Report

    Report Number
    3010266064-2020-00932
    Event Type
    Malfunction
    Date Received
    April 24, 2020
    Date of Event
    February 23, 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
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE UPS WAS INTENDED FOR USE IN TREATMENT, UPS REPORTED A FALSE OVERLOAD CONDITION AND BEEPED AT REGULAR INTERVALS AS A RESULT OF THE CONDITION. THE DEVICE WAS RETURNED FOR EVALUATION. 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. VISUAL AND FUNCTIONAL INSPECTION CONFIRMED THAT THIS IS A KNOWN ISSUE WITH THIS MODEL OF THE UPS TO SHOW FALSE OVERLOAD ERRORS. THIS HAS BEEN RESOLVED IN A SOFTWARE UPDATE SO THAT THE SYSTEM DOES NOT PRECLUDE THE USER FROM PERFORMING A CASE WHEN THIS ISSUE OCCURS. THE REPORTED BEEN WAS LIKELY DUE TO THE UPS NOT BEING PLUGGED IN TO MITIGATE FUTURE OCCURRENCES. BASED ON THE INVESTIGATION, IT IS LIKELY THAT THE EVENT OCCURRED DUE TO THE REPORTED FAILURE. THE MALFUNCTION IS MOST PROBABLY DUE TO AN ELECTRICAL COMPONENT FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE A BRAND NEW INSTALLED UPS, IT IS REPORTING A KNOWN FALSE OVERLOAD CONDITION. THE UPS ALSO SOUNDS A BEEP AT REGULAR INTERVALS AS A RESULT OF THE CONDITION. SILENCED THE AUDIBLE TONE FROM THE UPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460552 OUS UPS 1ST GEN 200010 ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1