BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATIC ENDOSCOPE REPROCESSOR

    MDR report key: 1140669 · Received August 28, 2008

    Report

    Report Number
    2084725-2008-00544
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    August 6, 2008
    Report Date
    August 6, 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

    CAPITAL EQUIPMENT, UNIT EVALUATED AT THE FACILITY. THE FSE FOUND THE SYSTEM UP AND RUNNING WHEN HE ARRIVED. THE CUSTOMER EXPLAINED THAT THE BASIN FLOAT HAD BEEN KNOCKED OFF. THE CUSTOMER PLACED THE FLOAT, AND CAP BACK ON THE STEM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BASIN OF THEIR UNIT WAS OVERFLOWING, AND IT WOULDN'T COMPLETE A CYCLE. THE CUSTOMER STATED THAT THERE WERE NO PHYSICAL COMPLAINTS RELATED TO THE SMALL AMOUNT OF OPA THAT HAS ACTUALLY SPILLED OUT OF THE UNIT. 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 AUTOMATIC ENDOSCOPE REPROCESSOR ENDOSCOPE REPROCESSOR FEB ADVANCED STERILIZATION PRODUCTS NA NA

    Patients

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