BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR

    MDR report key: 1060226 · Received June 12, 2008

    Report

    Report Number
    2084725-2008-00266
    Event Type
    Injury
    Date Received
    June 12, 2008
    Date of Event
    May 16, 2008
    Report Date
    May 19, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FEB
    PMA / PMN Number
    K832458
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FSE CHECKED THE SYS AND ADJUSTED THE COMPRESSOR OUTPUT PRESSURE TO THE BASIN PORTS. THE OUTPUT PRESSURE WAS AT 15 PSI AND ADJUSTED IT BACK UP TO 20 PSI. THE FSE RECOMMENDED CUSTOMER TO CHANGE OUT THEIR WATER FILTRATION FILTERS AS FOLLOWS: THE 1.0 MICRON FILTER (ON THE LEFT OF THE FILTRATION SYS) SHOULD BE CHANGED EVERY MONTH. THE LARGER FILTER, 0.2 MICRON (ON THE RIGHT SHOULD BE CHANGED EVERY 6 MONTHS). THE FSE COMPLETED ALL SYS DIAGNOSTICS AND CHECKS. THE SYS IS OPERATING ACCORDING TO MFR'S SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ONE PT EXPERIENCED FEVER, CHILLS, NAUSEA, AND SYNCOPAL EPISODES. ACCORDING TO THE CT SCAN RESULT, THE PT ALSO EXPERIENCED "INFLAMMATION OF THE COLON." AFTER HAVING PROCEDURES. THE PT WAS PRESCRIBED ANTIBIOTICS. THE ASP FIELD SVC 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 ENDOSCOPE REPROCESSOR FEB ADVANCED STERILIZATION PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR CIDEX OPA