BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER

    MDR report key: 1111852 · Received August 13, 2008

    Report

    Report Number
    2084725-2008-00512
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 22, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FEB
    PMA / PMN Number
    K832458
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SOLUTION SPILL, CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FSE FOUND LEAK AT HEATER ELEMENT OF DISINFECTANT RESERVOIR. THE FSE REPLACED TANK, TESTED AND RAN EMPTY TEST CYCLE. UNIT IS OPERATING WITHIN MANUFACTURER'S SPECIFICATIONS. RESULTS - DISINFECTANT RESERVOIR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED "UNIT IS LEAKING CIDEX OPA." THERE WERE NO PHYSICAL COMPLAINTS REPORTED. THE ASP FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY TO ASSESS THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER ENDOSCOPE REPROCESSOR FEB ADVANCED STERILIZATION PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA CIDEX OPA