BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 1053217 · Received May 28, 2008

    Report

    Report Number
    2084725-2008-00237
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 1, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K991999
    Removal / Correction Number
    Z-1628-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OIL MIST, LABELED. CAPITAL EQUIPMENT, UNIT EVALUATED AT THE FACILITY. THE FSE CHANGED THE OIL MIST FILTER DURING PREVENTATIVE MAINTENANCE. THIS ISSUE IS BEING ADDRESSED WITH A CUSTOMER LETTER, RELATED TO CORRECTION & REMOVAL # 2084725-03/04/08-004C.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OIL MIST COMING FROM THE UNIT. THE CUSTOMER REPORTED THAT AN EMPLOYEE REPORT A NOSEBLEED AND NAUSEA WHILE WORKING IN THE ROOM WITH THE STERRAD. THE CUSTOMER REPORTED THAT THE EMPLOYEE DID NOT SEEK MEDICAL ATTENTION OR REQUIRE TREATMENT AS THE SYMPTOMS WENT AWAY WHEN HE STEPPED OUT OF THE ROOM. THE ASP 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 100S STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK