BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NY STERILIZATION SYSTEM

    MDR report key: 1032731 · Received April 22, 2008

    Report

    Report Number
    2084725-2008-00135
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 26, 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

    THE FSE REPLACED THE OIL MIST FILTER AND VERIFIED THAT OIL MIST WAS NO LONGER BEING EXPELLED.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED "DOOR HANDLE BROKEN" AND "NO SIGNAL". WHILE ON THE ASP FIELD SERVICE ENGINEER (FSE) NOTED THE UNIT EMITTING OIL MIST. THE FSE REPORTED THAT THE CUSTOMER DID NOT NOTICE THE OIL MIST DUE TO EXCEPTIONAL ROOM AIR VENTING. THE CUSTOMER STATED THAT THERE WERE NO PHYSICAL COMPLAINTS REPORTED. THE FSE REPAIRED THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD NY STERILIZATION SYSTEM STERILIZER MLR ADVANCED STERILIZATION PRODUCTS 10033 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA