BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER

    MDR report key: 1231076 · Received October 30, 2008

    Report

    Report Number
    2084725-2008-00713
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 6, 2008
    Manufacturer
    MINNTECH CORPORATION
    Product Code
    FEB
    PMA / PMN Number
    K832458
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER, TEMPERATURE LIGHT NOT ON - OTHER - CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FSE FOUND-BLOWN HEATER FUSE. THE FSE REPLACED HEATER FUSE AND TESTED UNIT. THE LIGHT CAME ON.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT'S TEMPERATURE LIGHT WAS NOT ON. THE CUSTOMER DID NOT RESPOND TO ASP'S ATTEMPTS ON RETRIEVING MORE INFORMATION. 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 UNK