BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM ULTRASONICS INC. SYSTEM 83 PLUS

    MDR report key: 2875743 · Received December 13, 2012

    Report

    Report Number
    2523209-2012-00005
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    October 12, 2012
    Report Date
    December 3, 2012
    Manufacturer
    CUSTOM ULTRASONICS INC.
    Product Code
    NVE
    PMA / PMN Number
    K983017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON 10/10/2012 THE SERVICE TECHNICIAN RECEIVED A CALL FROM THE GI SCOPE WASHER STATING THAT 4 BULKHEADS WERE BLOCKED. THE SERVICE TECHNICIAN THEN CONTACTED THE CHIEF ENGINEER TO ALERT HIM OF THE SITUATION. THE CHIEF ENGINEER WANTED HIS STAFF TO HANDLE THE REPAIR/REPLACEMENT OF THE BULKHEADS. ON 10/14/2012 THE CHIEF ENGINEER CALLED CUSTOM ULTRASONICS TO DISPATCH A SERVICE TECHNICIAN TO CHECK THE GI MACHINES FOR PROPER OPERATION. THE MACHINES WERE SHUT DOWN UNTIL THE SERVICE TECHNICIAN INSPECTED THEM FOR PROPER OPERATION, ON 10/15/2012 THE MACHINES WERE INSPECTED THE FLOW WAS GOOD. THE PARTS WERE NOT RETURNED TO THE MANUFACTURER. THE INVESTIGATION REVEALED THAT THE DISINFECTANT OF CHOICE AS PREVIOUSLY STATED ON MDR 2523209-2012-00004 MAY HAVE CAUSED THE BLOCKAGE. THERE WERE NO REPORTED INJURIES. DURING THIS TIME FRAME THERE MAY HAVE BEEN A LOW RISK OF INFECTION ASSOCIATED WITH THIS BREACH, CANNOT CONFIRM IF ANY RISK TO PATIENTS. CONTACTED THE GI MANAGER AND INFECTION CONTROL FOR ADDITIONAL INFORMATION, TO DATE NO RETURNED CALLS.

    Description of Event or Problem · 1

    NO FLOW THROUGH THE BULKHEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM ULTRASONICS INC. SYSTEM 83 PLUS MEDICAL WASHER - DISINFECTOR NVE CUSTOM ULTRASONICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1