BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 1231055 · Received October 30, 2008

    Report

    Report Number
    2084725-2008-00716
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 1, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K991999
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HUMAN REACTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ONE OF HER EMPLOYEES IS PREGNANT AND CLAIMED THAT WHEN SHE IS NEAR THE STERILIZER (WITHIN 4 FEET) WHILE IT IS IN OPERATION SHE FEELS "DIZZY". THE EMPLOYEE EXPERIENCED THE SYMPTOM INTERMITTENTLY THROUGH OUT THE DAY. THE EMPLOYEE ALSO REPORTED THAT AS SOON AS SHE WALKS AWAY SHE IS FINE. THE EMPLOYEE DID NOT SEEK MEDICAL ATTENTION OR REQUIRE TREATMENT. THE CUSTOMER REPORTED THAT THERE WERE NO ODORS, SMELLS OR OIL MIST NOTED FROM THE STERILIZER. THE UNIT IS AND HAS BEEN WORKING WITH NO PROBLEMS. THE CUSTOMER'S SAFETY DEPARTMENT WILL BE PERFORMING AIR SAMPLING TESTS TO ASSURE WE ARE IN COMPLIANCE WITH THE REGS. THE ASP CUSTOMER CARE PROVIDED A LETTER TO THE CUSTOMER IN REGARDS TO AIR MONITORING IN CONJUNCTION WITH THE USE OF THE STERRAD UNITS.

    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 22 YR