BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZER

    MDR report key: 1111840 · Received August 13, 2008

    Report

    Report Number
    2084725-2008-00518
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 14, 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
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OIL MIST - CAPITAL EQUIPMENT, UNIT EVALUATED AT THE FACILITY. THE FSE REPLACED THE OIL MIST MANIFOLD AND FILTER. HE RAN A FEW DIAGNOSTICS. THIS ISSUE IS BEING ADDRESSED WITH A CUSTOMER LETTER, RELATED TO CORRECTION & REMOVAL.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED A CUSTOMER WHO EXPERIENCED A "LITTLE HAZE IN THE ROOM". THE FIELD SERVICE ENGINEER (FSE) STATED THAT HE DID NOT BELIEVE THAT THERE WERE ANY PHYSICAL COMPLAINTS. THE 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 NA