BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM 83+2

    MDR report key: 875871 · Received July 6, 2007

    Report

    Report Number
    2523209-2007-00023
    Event Type
    Death
    Date Received
    July 6, 2007
    Date of Event
    August 18, 2000
    Report Date
    August 18, 2000
    Manufacturer
    CUSTOM ULTRASONICS, INC
    Product Code
    FLG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INVESTIGATION, IT WAS DETERMINED THAT THE PREVENTIVE MAINTENANCE ON WATER FILTERS WAS NEVER PERFORMED ACCORDANCE TO THE THREE MONTH SCHEDULE CLEARLY STATED IN THE USER'S MANUAL THAT IS ISSUED WITH EVERY DEVICE. IT WAS ALSO FOUND THAT THE FILTERS IN THE UNIT WERE NON-OEM RECOMMENDED FILTERS AND ONE WAS IMPROPERLY INSTALLED WHICH CRUSHED THE O-RINGS. CU PERFORMED PREVENTIVE MAINTENANCE AND PERFORMED STERILIZATION PROCEDURES ON THE FILTER HOUSING. PROPER OEM FILTERS WERE INSTALLED. THE FACILITY USERS WERE RE-TRAINED ON FILTER MAINTENANCE AND PREVENTIVE MAINTENANCE.

    Description of Event or Problem · 1

    POSSIBLE PATIENT INFECTION WITH A WATERBORNE MICROORGANISM WHO SUBSEQUENTLY DIED AFTER TRANSFER TO ANOTHER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 83+2 ULTRASONIC MEDICAL EQUIPMENT CLEANER FLG CUSTOM ULTRASONICS, INC 83+2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death