BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZATION SYSTEM

    MDR report key: 1003333 · Received February 27, 2008

    Report

    Report Number
    2084725-2008-00034
    Event Type
    Malfunction
    Date Received
    February 27, 2008
    Date of Event
    January 29, 2008
    Report Date
    January 29, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K042116
    Removal / Correction Number
    Z-1631-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE REPLACED THE OIL MIST FILTER ASSEMBLY AND THEN TESTED THE UNIT. THE UNIT MET ALL MANUFACTURER SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A "CLOUD OF SMOKE" IN THE ROOM THAT WAS COMING FROM THE UNIT. THE CUSTOMER STATED THAT THERE WERE NO PHYSICAL INJURIES REPORTED. THE ASP FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY AND 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