BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER

    MDR report key: 1060766 · Received June 12, 2008

    Report

    Report Number
    2084725-2008-00269
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 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
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FSE REPLACED THE QUICK DISCONNECT FITTINGS. THE FSE TESTED THE UNIT AND FOUND IT OPERATING TO MANUFACTURING SPECIFICATIONS. RESULT: QUICK DISCONNECT FITTINGS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE RESERVOIR TANK WAS OVERFLOWING AND LEAKING CIDEX OPA. CIDEX OPA WAS FAILING AFTER 4-5 DAYS. THERE WERE NO PHYSICAL SYMPTOMS 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