BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER

    MDR report key: 1140671 · Received August 28, 2008

    Report

    Report Number
    2084725-2008-00545
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 7, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FEB
    PMA / PMN Number
    K832458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAPITAL EQUIPMENT, UNIT EVALUATED AT THE FACILITY. THE FSE REPLACED THE RESERVOIR TANK WITH THE HEATER AND VERIFIED PROPER OPERATION. HE VERIFIED THAT THE SYSTEM MET SPECIFICATIONS. HE RAN AN EMPTY WASH AND DISINFECT CYCLE THAT PASSED OKAY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TEMPERATURE LIGHT NOW WORKING. THE CUSTOMER REPORTED THAT THEY INCREASED THE CYCLE TIME. THE CUSTOMER STATED THAT THEY DID NOT HAVE ANY REPORTS OF PATIENT INJURY. THE ASP FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY TO REPAIR THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER ENDOSCOPE REPROCESSOR FEB ADVANCED STERILIZATION PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA