BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER

    MDR report key: 1230847 · Received November 6, 2008

    Report

    Report Number
    2084725-2008-00725
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 17, 2008
    Report Date
    October 17, 2008
    Manufacturer
    MINNTECH CORP
    Product Code
    FEB
    PMA / PMN Number
    K832458
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SOLUTION SPILL: CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FSE FOUND ASP AER LEAKING CIDEX OPA FROM THE HEATER ON THE TANK ASSEMBLY. THE FSE REMOVED AND REPLACED THE TANK ASSEMBLY. THE FSE RAN WASH AND DISINFECT CYCLE. UNIT PERFORMS WITHIN MANUFACTURERS SPECIFICATIONS. RESULTS - TANK.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT THE UNIT WAS LEAKING CIDEX OPA AT THE BOTTOM OF THE RESERVOIR. THERE WERE NO PHYSICAL COMPLAINTS 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 MINNTECH CORP NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA CIDEX OPA: CATALOG # : 20390