BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZER

    MDR report key: 1083342 · Received July 28, 2008

    Report

    Report Number
    2084725-2008-00414
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    August 2, 2007
    Report Date
    August 2, 2007
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K042116
    Removal / Correction Number
    2084725-03/04/08-004C
    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 UNIT PRODUCING OIL MIST. HE REPLACED THE OIL MIST ELIMINATOR WITH ALCATEL OME. THE FSE RAN AN EMPTY CHAMBER TEST CYCLE AND THE UNIT MET SPECIFICATIONS. THIS ISSUE IS BEING ADDRESSED WITH A CUSTOMER LETTER, RELATED TO CORRECTION & REMOVAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A "FOG" COMING FROM THE UNIT. THE EMPLOYEE COMPLAINED OF DRYNESS OF THE THROAT AND BLURRY EYES. THE EMPLOYEE DID NOT SEEK MEDICAL ATTENTION OR REQUIRE TREATMENT FOR HER SYMPTOMS. THE FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY TO REPAIR THE UNIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK