BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER

    MDR report key: 1140674 · Received August 28, 2008

    Report

    Report Number
    2084725-2008-00548
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 4, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FEB
    PMA / PMN Number
    K832458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FLUID LEAKING FROM UNIT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR UNIT WAS LEAKING BLUE FLUID THAT THEY BELIEVED WAS CIDEX FROM THE RIGHT, FRONT SIDE OF THE UNIT. THE CUSTOMER REPORTED THAT THERE WAS FLUID ON THE FLOOR WHEN THEY CAME IN THAT MORNING. THE CUSTOMER REPORTED THAT THE LEAK WAS SLOW. THE CUSTOMER STATED THAT THERE WERE NO PHYSICAL COMPLAINTS REPORTED. THE CUSTOMER STATED THAT THEY WOULD REPAIR THE UNIT THEMSELVES.

    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 CIDEX OPA: CATALOG# 20390