BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERRAD NX STERILIZER

    MDR report key: 1163609 · Received September 17, 2008

    Report

    Report Number
    2084725-2008-00567
    Event Type
    Injury
    Date Received
    September 17, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WATERY EYES, DRY THROAT, AND RUNNY NOSE - OIL MIST - CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FSE FOUND OIL MIST. THE FSE REPLACED OIL MIST FILTER ASSEMBLY AND VACUUM PUMP. CERTIFIED SYSTEM WITH DIAGNOSTICS AND EMPTY CYCLE. SYSTEM MEETS SPECIFICATIONS. CONCLUSION - CUSTOMER LETTER WAS SENT TO ALL STERRAD CUSTOMERS TO REINFORCE THE IMPORTANCE OF CANCELLING THE CYCLE, LEAVING THE ROOM AND DISCONTINUE USE OF THE UNIT UNTIL THE UNIT IS REPAIRED IF THE MIST ISSUE OCCURS. A USER GUIDE EXCERPT THAT ADDED A WARNING WAS SENT WITH THE CUSTOMER LETTER. REFERENCE MDR 2084725-2008-00581 FOR EMPLOYEE #2 (2 OF 2) WITH UNK SYMPTOMS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OIL MIST/HAZE COMING FROM THE UNIT. THE CUSTOMER ALSO REPORTED THAT HE AND ANOTHER EMPLOYEE EXPERIENCED SYMPTOMS. THE CUSTOMER REPORTED THAT HE WAS EXPERIENCING "WATER EYES, HEADACHE, DRY THROAT AND RUNNY NOSE." THE CUSTOMER DID NOT SEEK MEDICAL ATTENTION OR REQUIRE TREATMENT. HE WAS NOT AWARE OF THE OTHER EMPLOYEE'S SYMPTOMS. THE ASP FIELD SERVICE ENGINEER (FSE) 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