BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZATION SYSTEM

    MDR report key: 1053208 · Received May 28, 2008

    Report

    Report Number
    2084725-2008-00230
    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
    K042116
    Removal / Correction Number
    Z-1631-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FSE UPGRADED THE OIL MIST FILTER TO THE ALCATEL FILTER. THE UNIT MET MANUFACTURER SPECIFICATIONS. THIS ISSUE IS BEING ADDRESSED WITH A CUSTOMER LETTER, RELATED TO CORRECTION & REMOVAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT OIL MIST WAS "FILLING THEIR ROOM". THE CUSTOMER REPORTED A BURNING SENSATION OF THE EYES. SHE DID NOT SEE A DOCTOR OR REQUIRE TREATMENT. 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 NX STERILIZATION SYSTEM STERILIZER MLR ADVANCED STERILIZATION PRODUCTS 10033 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK