BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZATION SYSTEM

    MDR report key: 1052317 · Received May 22, 2008

    Report

    Report Number
    2084725-2008-00177
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 26, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K042116
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAPITAL EQUIPMENT, ASSESSED AT CUSTOMER SITE. THE FSE REPLACED THE MIST FILTER ASSEMBLY. HE RAN A SUCCESSFUL EMPTY CHAMBER CYCLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CHAMBER PUMPDOWN ERROR AND VACUUM SYSTEM FAILURE. WHILE ONSITE TO SERVICE THE UNIT, THE ASP FIELD SERVICE ENGINEER (FSE) FOUND OIL MIST COMING FROM THE UNIT. THE CUSTOMER STATED THAT THERE WERE NO PHYSICAL COMPLAINTS REPORTED. THE FSE REPAIRED THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD NX STERILIZATION SYSTEM STERILIZER MLR ADVANCED STERILIZATION PRODUCTS 10033 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA