BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER

    MDR report key: 1082508 · Received July 24, 2008

    Report

    Report Number
    2084725-2008-00405
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 12, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAPITAL EQUIPMENT, UNIT EVALUATED AT THE FACILITY. THE FSE FOUND FLUID ON THE FLOOR OF THE UNIT. HE FOUND THE TANK LEAKING FROM THE HEATER ASSEMBLY ON THE TANK. HE REPLACED THE TANK AND VERIFIED THE SYSTEM SPECIFICATIONS. HE RAN AN EMPTY CYCLE AND THE UNIT MET MANUFACTURE SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR RESERVOIR WAS LEAKING DISINFECTANT. THE CUSTOMER CONFIRMED THAT CIDEX OPA WAS LEAKING FROM THE UNIT. 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 ENDOSCOPE REPROCESSOR FEB ADVANCED STERILIZATION PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA CIDEX OPA