BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZER

    MDR report key: 1171519 · Received September 17, 2008

    Report

    Report Number
    2084725-2008-00587
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 27, 2008
    Report Date
    August 27, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER: SCRATCHY THROAT. CAPITAL EQUIPMENT , EVALUATED AT CUSTOMER SITE. THE FSE FOUND REAR OIL FILL CAP ON VACUUM PUMP, DEVELOPED HOLE, AND WAS VENTING AIR AND AIR MISTED OIL OUT OF VACUUM PUMP WHEN STERILIZER WAS IN OPERATION. THERE WAS NO OBSERVABLE OIL MIST COMING FROM THE FILTER. THE DECISION WAS MADE TO REMOVE THE VACUUM PUMP AND OIL MIST FILTER. THE EXISTING CATALYTIC CONVERTER WAS MOUNTED TO A NEW OIL MIST FILTER HOUSING. THE NEW VACUUM PUMP WAS INSTALLED AND THE NEW OIL MIST FILTER WAS INSTALLED. IT WAS VERIFIED THAT THE FILTER WAS WORKING CORRECTLY AND THERE WAS NO OIL MIST. A LEAK BACK WAS PERFORMED WITH SATISFACTORY RESULTS AND THE STANDARD CYCLE WAS UNREMARKABLE. THE UNIT WAS DEEMED ACCEPTABLE FOR USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED "SMOKE/ODOR AND HAZE" IN THE ROOM WHEN THE UNIT WAS RUNNING. THE CUSTOMER REPORTED THAT AN EMPLOYEE EXPERIENCE SCRATCHY THROAT. THE EMPLOYEE DID NOT SEEK ANY MEDICAL ATTENTION AND 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 27 YR