BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 83 PLUS 2

    MDR report key: 5050939 · Received September 2, 2015

    Report

    Report Number
    3007082252-2015-00010
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Date of Event
    August 12, 2015
    Report Date
    August 12, 2015
    Manufacturer
    CUSTOM ULTRASONICS INC.
    Product Code
    FEB
    PMA / PMN Number
    K983017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE NO REPORTED INJURIES ASSOCIATED WITH THIS EVENT. THE REPORTED SYMPTOM WAS ATTRIBUTED TO A FAILED TRANSDUCER CRYSTAL/NOSE AND TAIL PC ASSEMBLY, P/N 12061, AND WAS LIKELY CAUSED BY LIQUID INGRESS THAT CREATED A SHORTING CONDITION TO THE TRANSDUCER WIRE. THE RETURNED ULTRASONIC GENERATOR (500 W) BOARD, P/N 12008, DATE CODE JAN. 11, 2011, WAS FOUND TO PERFORM AS INTENDED.

    Description of Event or Problem · 1

    DURING A SITE VISIT TO INSTALL A UFAS, THE SERVICE TECHNICIAN NOTICED THAT THE ULTRASONICS WERE NOT FUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583110 SYSTEM 83 PLUS 2 ENDOSCOPE WASHER DISINFECTOR FEB CUSTOM ULTRASONICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1