BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATIC ENDOSCOPE REPROCESSOR

    MDR report key: 1063762 · Received June 19, 2008

    Report

    Report Number
    2084725-2008-00289
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    April 18, 2008
    Report Date
    April 18, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FSE REMOVED SKINNER VALVE, AND FOUND A PIECE OF RUBBER TUBING IN THE VALVE SEALING SURFACE. THE FSE REMOVED THE PIECE, AND RAN EMPTY CYCLE SUCCESSFULLY. THE SYSTEM WAS FOUND TO MANUFACTURER SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED "SYSTEM OVERFLOWING" WITH CIDEX ON TO THE FLOOR. THERE WERE NO PHYSICAL COMPLAINT RELATED TO THE OVERFLOW OF CIDEX. 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 AUTOMATIC ENDOSCOPE REPROCESSOR ENDOSCOPE REPROCESSOR FEB ADVANCED STERILIZATION PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA UNK CIDEX SOLUTION