BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM ULTRASONICS INC SYSTEM 83 PLUS 2

    MDR report key: 2904736 · Received January 4, 2013

    Report

    Report Number
    2523209-2013-00001
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 6, 2012
    Report Date
    January 2, 2013
    Manufacturer
    CUSTOM ULTRASONICS
    Product Code
    KOG
    PMA / PMN Number
    K983017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION REVEALED THAT THE UNIT HAD 4 CLOGGED DISK FILTERS, 2 AIR FEED AND 2 WATER CHANNEL DISKS. THE OFFICE SUPERVISOR IS NEW TO THIS POSITION AND WAS UNAWARE OF THE REQUIRED MAINTENANCE TO CHANGE THE DISK EVERY 6-8 WEEKS, AS STATED IN THE OPERATOR'S MANUAL AND STAMPED ON THE ACTUAL DISK. THE SUPERVISOR DID NOT KNOW WHEN THE FILTER DISK BECAME OCCLUDED, MAY HAVE BEEN 7 MONTHS AGO WHEN SHE TOOK OVER THIS POSITION. THE TECH ALSO NOTICED THAT THE INCORRECT ADAPTERS WERE BEING USED TO CLEAN THE SCOPES AND ADVISED THE FACILITY NOT TO USE OR PROCESS THE SCOPES UNTIL THE CORRECT ADAPTERS WERE SUPPLIED. HOSPITAL WAS ADVISED OF INCREASED RISK TO PTS DUE TO INCORRECT PROCESSING OF THESE SCOPES. CUSTOM ULTRASONICS DID PERFORM PREVENTIVE MAINTENANCE, REPLACED THE ADAPTERS, AND RETRAINED THE STAFF. THERE WERE NO REPORTED INJURIES. DURING THIS TIME FRAME, THERE MAY HAVE BEEN AN INCREASED OF INFECTION ASSOCIATED WITH THIS BREACH, COULD NOT CONFIRM IF ANY RISK TO PTS.

    Description of Event or Problem · 1

    DISC FILTERS COMPLETELY OCCLUDED ON AIR AND WATER CHANNELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5438 CUSTOM ULTRASONICS INC SYSTEM 83 PLUS 2 MEDICAL WASHER-DISINFECTOR KOG CUSTOM ULTRASONICS

    Patients

    Seq Age Sex Outcome Treatment
    1