BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZER

    MDR report key: 1191217 · Received September 26, 2008

    Report

    Report Number
    2084725-2008-00597
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 10, 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
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FSE REPLACED VACUUM PUMP CAP. THE FSE RAN A STANDARD CYCLE. MACHINE MEETS MFG SPECIFICATIONS. RESULTS CODES: VACUUM CAP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A STRONG ODOR AND HAZE WERE COMING FROM THE UNIT WHEN PROCESSING LOAD. THE CUSTOMER REPORTED THAT THIS HAS CAUSED FOR AN EMPLOYEE'S THROAT TO GO DRY AND MADE HER COUGH. THE EMPLOYEE DID NOT SEEK MEDICAL ATTENTION OR REQUIRE TREATMENT. THE ASP FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY TO ASSESS 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 46 YR