BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERRAD NX STERILIZER

    MDR report key: 1060229 · Received June 12, 2008

    Report

    Report Number
    2084725-2008-00276
    Event Type
    Injury
    Date Received
    June 12, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 20, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K042116
    Removal / Correction Number
    Z-1631-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FSE INSTALLED OIL MIST FILTER KIT. CERTIFIED SYS WITH DIAGNOSTICS AND EMPTY CYCLE. SYS MEETS SPECIFICATIONS. THIS ISSUE HAS BEEN ADDRESSED WITH A CUSTOMER LETTER RELATED TO CORRECTION & REMOVAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OIL MIST; HAZE COMING FROM THE UNIT. ALSO, THE CUSTOMER REPORTED THAT SHE FELT LIGHT-HEADED AND DEVELOPED A SLIGHT HEADACHE. IN ADDITION, SHE EXPERIENCED SHORTNESS OF BREATH. THE CUSTOMER DID NOT SEEK MEDICAL ATTENTION. THE ASP FIELD SVC ENGINEER (ASP) WENT TO THE FACILITY TO ASSESS 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