BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER

    MDR report key: 1363317 · Received January 16, 2009

    Report

    Report Number
    2084725-2009-00002
    Event Type
    Malfunction
    Date Received
    January 16, 2009
    Date of Event
    December 18, 2008
    Report Date
    December 18, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    NVE
    PMA / PMN Number
    K832458
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER: CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FSE REPLACED THE RESERVOIR FOR A CRACK AROUND THE HEATER. THE FSE RAN WASH/DISINFECT TEST CYCLE. THE FSE STATED THAT THE CRACK WOULD LET CIDEX LEAK OUT OF THE RESERVOIR. HOWEVER, THE FSE COULD NOT CONFIRM WHAT WAS LEAKING OUT OF THE AER SINCE THE RESERVOIR WAS EMPTY UPON HIS ARRIVAL.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT THE UNIT WAS LEAKING FLUID. THERE WERE NO INJURIES 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 AER EQUIPMENT NVE ADVANCED STERILIZATION PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA UNK CIDEX SOLUTION