BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROSSOR WITH PRINTER

    MDR report key: 1171526 · Received September 17, 2008

    Report

    Report Number
    2084725-2008-00582
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 21, 2008
    Manufacturer
    UNITROL/MINNTECH COR
    Product Code
    FEB
    PMA / PMN Number
    K832458
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE CUSTOMER REQUESTED PART NUMBER FOR THE DISINFECTANT RESERVOIR. UPON FOLLOW UP BY ASP, THE CUSTOMER STATED THAT THE UNIT WAS NOW WORKING. CUSTOMER REPAIRED UNIT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT WAS LEAKING CIDEX SOLUTION. THERE WERE NO PHYSICAL COMPLAINTS REPORTED RELATED TO THE LEAK. THE ASP TECHNICAL SERVICES PROVIDED THE CUSTOMER THE PART NUMBER TO REPAIR THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASP AUTOMATIC ENDOSCOPE REPROSSOR WITH PRINTER ENDOSCOPE REPROCESSOR FEB UNITROL/MINNTECH COR NA NA

    Patients

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