BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZER

    MDR report key: 1060774 · Received June 12, 2008

    Report

    Report Number
    2084725-2008-00279
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 5, 2008
    Report Date
    May 22, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IRRITATED EYES- CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FIELD ENGINEER REPLACED THE OIL MIST FILTER. SINCE THE FILTER WAS REPLACED THE CUSTOMER HAS EXPERIENCED NO ONGOING PROBLEMS. THIS ISSUE HAS BEEN ADDRESSED WITH A CUSTOMER LETTER RELATED TO CORRECTION & REMOVAL #2084725.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT EXPERIENCED ONE WEEK OF A HEAVY MIST IN THEIR STERILIZING DEPARTMENT. THE CUSTOMER REPORTED THAT ONE OF THE EMPLOYEES EXPERIENCED IRRITATED EYES. THE CUSTOMER DID NOT SEE A DOCTOR OR REQUIRE TREATMENT FOR THE SYMPTOM. FIELD ENGINEER WENT TO THE FACILITY AND ASSESSED 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 UNK