BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER

    MDR report key: 1213691 · Received October 23, 2008

    Report

    Report Number
    2084725-2008-00692
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 1, 2008
    Manufacturer
    MINNTECH CORPORATION
    Product Code
    FEB
    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 FOUND THAT THE HEATER FUSE LOCATED ON THE CONTROL PCB HAD OPENED UP AND WOULD NOT ALLOW HEATER TO FUNCTION. SOLUTION: THE FSE REMOVED OLD FUSE, CLEANED CONTACTS AND REPLACED WITH NEW FUSE. THE FSE RAN HEATER TEST AND EMPTY TEST CYCLE. THE FSE VERIFIED SYSTEM MEETS SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TEMPERATURE INDICATOR LIGHT WAS NOT ON. THE CUSTOMER REPORTED THAT THEY HAVE BEEN USING THE AUTOMATIC ENDOSCOPE REPROCESSOR SINCE 2008, AND JUST NOTICED 3 WEEKS AGO THAT THE TEMP LIGHT WAS NOT ON. CUSTOMER WAS CONCERNED THAT THE SCOPES THAT HAVE BEEN PROCESSED AND USED ON PATIENTS WERE NOT CLEANED PROPERLY. THE CUSTOMER CONFIRMED THAT THERE HAVE NOT BEEN ANY COMPLICATIONS OR INJURIES. 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 CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA