BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUBESCAN

    MDR report key: 14048423 · Received April 7, 2022

    Report

    Report Number
    3007740628-2022-00001
    Event Type
    Malfunction
    Date Received
    April 7, 2022
    Date of Event
    March 12, 2022
    Report Date
    March 31, 2022
    Manufacturer
    MCUBE TECHNOLOGY CO., LTD.
    Product Code
    IYO
    UDI-DI
    08809458500009
    PMA / PMN Number
    K171591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT STAFF PLUGGED IN THE DEVICE AND THEY SAID IT SPARKED AND LOOKS LIKE THERE WAS SMOKE. AND IT WAS ALSO REPORTED THAT THERE IS NO PATIENT INVOLVED IN THE EVENT AND THE POWER CORD AND INLET OF THE DEVICE WERE REPLACED BY A FIELD SERVICE ENGINEER. MCUBE TECHNOLOGY INVESTIGATED THE POWER CORD AND INLET AND FOUND THAT AMONG THE 3 PINS OF THE INLET, THE GROUND PIN WAS DAMAGED, AND IT WAS INSERTED INTO THE PLUG. THE CAUSE OF THE EVENT COULD NOT BE CONFIRMED. THE POWER CORD AND INLET WERE UL APPROVED AND THE ELECTRICAL SAFETY OF THE DEVICE COMPLIES WITH IEC60601-1.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STAFF PLUGGED IN DEVICE AND THEY SAID IT SPARED AND LOOKS LIKE THERE WAS SMOKE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STAFF PLUGGED IN DEVICE AND THEY SAID IT SPARKED AND LOOKS LIKE THERE WAS SMOKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171351 CUBESCAN BLADDER VOLUME MEASUREMENT SYSTEM IYO MCUBE TECHNOLOGY CO., LTD. BIOCON-900 08809458500009

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown