BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUS UPS 2ND GEN

    MDR report key: 9993622 · Received April 23, 2020

    Report

    Report Number
    3010266064-2020-00368
    Event Type
    Malfunction
    Date Received
    April 23, 2020
    Date of Event
    November 10, 2016
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10 H3, H6: THE DEVICE WAS INTENDED FOR USE IN TREATMENT. THE NEW UPS WAS INSTALLED, HOWEVER, WHEN IT WAS TURNED ON IT DISPLAYED AN INTERNAL POWER FAILURE ERROR. THE BOOT SEQUENCE REACHED THE BLUE SPLASH SCREEN WHEN THE ERROR OCCURS. THE RED OVERLOAD LIGHT ON THE UPS ALSO WAS COMING ON. THE DEVICE WAS NOT MADE AVAILABLE TO THE DESIGNATED COMPLAINT UNIT FOR INVESTIGATION. THUS, VISUAL AND FUNCTIONAL INVESTIGATION COULD NOT BE PERFORMED. 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. WE COULD NOT CONFIRM IF THERE WAS A RELATIONSHIP ESTABLISHED BETWEEN THE REPORTED EVENT AND THE DEVICE. PHOTOS OF THE DEVICE WERE SENT DISPLAYING THE FAILURE BUT THE DEVICE WAS NOT RETURNED AND THE ROOT CAUSE COULD NOT BE DETERMINED. A FACTOR THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE IS IF THE SYSTEM WAS BOOTED UP WHILE IT WAS PLUGGED INTO WALL POWER. IT HAS BEEN FOUND IN PREVIOUS COMPLAINTS THAT THE UPS WILL HAVE AN ISSUE WITH BOOTING UP AT 50 HZ. A CAPA WAS OPENED FOR THIS ISSUE. THE NAVIO USER MANUAL ADDENDUM WAS UPDATED TO INCLUDE CHANGES TO INSTRUCT USERS TO BOOT THE SYSTEM DISCONNECTED FROM WALL POWER AND PLUG THE SYSTEM INTO THE WALL AFTER BOOT UP IF THE SYSTEM FAILS TO BOOT PLUGGED INTO WALL POWER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SALES REP INSTALLED THE NEW UPS; HOWEVER, WHEN HE TURNED IT ON HE RECEIVED AN INTERNAL POWER FAILURE ERROR. THE BOOT SEQUENCE REACHED THE BLUE SPLASH SCREEN WHEN THE ERROR OCCURS. THE RED OVERLOAD LIGHT ON THE UPS ALSO WAS COMING ON. NO DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456217 OUS UPS 2ND GEN ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1