BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZATION SYSTEM

    MDR report key: 1003332 · Received February 27, 2008

    Report

    Report Number
    2084725-2008-00035
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE REPLACED THE OIL MIST FILTER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED "WHITE SMOKE" COMING FROM THE UNIT. THE CUSTOMER REPORTED HEADACHE AND EYE IRRITATION WHEN WORKING AROUND THE UNIT WITH THIS ISSUE. THE CUSTOMER DID NOT SEE A DOCTOR OR REQUIRE TREATMENT FOR THE SYMPTOMS. THE ASP FIELD SERVICE ENGINEER (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 UNK