BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZATION SYSTEM

    MDR report key: 1040857 · Received May 9, 2008

    Report

    Report Number
    2084725-2008-00160
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 14, 2008
    Report Date
    April 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
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CAPITAL EQUIPMENT, FSE WENT TO THE FACILITY. THE FSE REPLACED THE OIL MIST FILTER ASSEMBLY AND TESTED THE UNIT. HE RAN AN EMPTY TEST CYCLE AND THE UNIT MET SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE ROOM GETTING "CLOUDY". THE CUSTOMER STATED THAT ONE EMPLOYEE COMPLAINED OF "HEADACHE" BUT DID NOT SEEK MEDICAL ATTENTION OR RECEIVE TREATMENT FOR THE SYMPTOM. THE CUSTOMER DECLINED TO SHARE IDENTIFYING INFO ABOUT THE EMPLOYEE. THE ASP FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY AND 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