BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER

    MDR report key: 1111859 · Received August 13, 2008

    Report

    Report Number
    2084725-2008-00471
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 16, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FEB
    PMA / PMN Number
    K832458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CIDEX SOLUTION LEAK, CAPITAL EQUIPMENT, UNIT EVALUATED AT THE FACILITY. THE FSE REPLACED THE MAIN HARNESS AND THE DISINFECTANT VALVE. SHE COMPLETED ALL SYSTEM CHECKS AND THE SYSTEM WAS OPERATING ACCORDING TO MANUFACTURER SPECIFICATIONS. HARNESS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR UNIT WAS "LEAKING CIDEX IN THREE PLACES". THE CUSTOMER REPORTED THAT THE UNIT WAS LEAKING UNDER THE LEFT SIDE OF THE UNIT, THE BOTTOM OF THE UNIT, AND THE RIGHT BACK. THE CUSTOMER STATED THAT THERE WERE NO PHYSICAL COMPLAINTS REPORTED. THE ASP FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY TO REPAIR THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER NONE FEB ADVANCED STERILIZATION PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA CIDEX OPA