BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER

    MDR report key: 1203246 · Received October 17, 2008

    Report

    Report Number
    2084725-2008-00662
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 25, 2008
    Manufacturer
    MINNTECH CORP
    Product Code
    FEB
    PMA / PMN Number
    K832458
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SOLUTION SPILL. CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FSE REPLACED THE V2 DISINFECTANT PUMP VALVE AND VERIFIED PROPER OPERATION. THE FSE VERIFIED THAT THE AER WAS NOT LEAKING OPA. THE FSE VERIFIED THAT THE SYSTEM MEETS SPECIFICATIONS. THE FSE RAN AN EMPTY WASH AND THE DISINFECT CYCLE WAS OK.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT THE UNIT WAS LEAKING CIDEX OPA. THE CUSTOMER CONFIRMED THAT IT WAS A TEAL COLOR WITH AN ODOR. THERE WERE NO INJURIES INVOLVED. THE UNIT DISPLAYED E01 ERROR AND THE CUSTOMER CHANGED THE DISINFECTANT AFTER THE TEST STRIP FAILED. 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