BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZER

    MDR report key: 1213692 · Received October 23, 2008

    Report

    Report Number
    2084725-2008-00691
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 1, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K042116
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DRY IRRITATED THROAT AND IRRITATED EYES) - (OIL MIST) - CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FSE REPLACED THE VACUUM PUMP ASSEMBLY DUE TO OIL CAPS LEAKING OIL MIST. THE FSE REPLACED THE VACUUM PUMP EXHAUST FILTER ASSEMBLY. THE FSE REPLACED THE OIL RETURN VALVE. THE FSE PERFORMED VACUUM SUBSYSTEM TEST PROCEDURE AND PERFORMED TEMPERATURE VERIFICATION PROCEDURE. THE FSE RAN AN EMPTY CHAMBER TEST CYCLE. SYSTEM MEETS ALL MANUFACTURE SPECIFICATIONS. OIL CAP. REFERENCE: MDR 2084725-2008-00689 AND MDR 2084725-2008-00690.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OIL MIST HAZE WAS COMING FROM THE UNIT. IT HAD A BURNING SMELL AND THEY NOTICED OIL ON THE FAN LOCATED ON THE BACK PANEL OF THE STERRAD. THE HAZE FILLED THE ROOM. THIS HAS BEEN INTERMITTENT FOR THE PAST 2 WEEKS. DURING CERTAIN STAGES OF THE CYCLE, WHEN THE VACUUM PUMP WAS ACTIVATED, THEY NOTICED THE HAZE. THERE WERE NO CANCELLATIONS. THE CUSTOMER REPORTED THREE EMPLOYEES HAVING EXPERIENCED SYMPTOMS. THE EMPLOYEES DID NOT GO TO THE EMERGENCY ROOM. THEY CHOSE TO WEAR FACE MASKS INSTEAD. THE THIRD OF THE THREE EMPLOYEES EXPERIENCED DRY THROAT IRRITATION AND EYE IRRITATION. 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 27 YR