BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZER

    MDR report key: 1171522 · Received September 17, 2008

    Report

    Report Number
    2084725-2008-00581
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 29, 2008
    Report Date
    August 29, 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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER - CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FSE FOUND OIL MIST. REPLACED OIL MIST FILTER ASSEMBLY AND VACUUM PUMP. CERTIFIED SYSTEM WITH DIAGNOSTICS AND EMPTY CYCLE. SYSTEM MEETS SPECIFICATIONS. CONCLUSION CODE - OTHER - 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 (LC-100799) THAT ADDED A WARNING WAS SENT WITH THE CUSTOMER LETTER. REFERENCE MDR 2084725-2008-00567 FOR EMPLOYEE #1 (1 OF 2) WITH "WATERY EYES, HEADACHE, DRY THROAT AND RUNNY NOSE" 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. HOWEVER, THE CUSTOMER INITIALLY REPORTED THAT HE WAS NOT AWARE OF THE OTHER EMPLOYEE'S SYMPTOMS. THE CUSTOMER DID NOT RESPOND TO ASP'S ATTEMPT IN RETRIEVING MORE INFORMATION REGARDING THE EMPLOYEE WITH UNKNOWN SYMPTOMS. THE ASP FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY TO ACCESS 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