BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100NX STERILIZER

    MDR report key: 4953405 · Received July 30, 2015

    Report

    Report Number
    2084725-2015-00174
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    July 9, 2015
    Report Date
    July 9, 2015
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K071385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER SITE. HAZE/MIST/VAPOR WAS CONFIRMED. A CORRECTIVE MAINTENANCE WAS PERFORMED AND THE OIL RETURN VALVE WAS TIGHTENED. UNIT MEETS SPECIFICATIONS AND WAS RETURNED TO SERVICE ON (B)(6) 2015.

    Additional Manufacturer Narrative · 1

    (B)(4). ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD (DHR), SERVICE HISTORY, FAILURE MODE AND EFFECTS ANALYSIS (FMEA), AND SYSTEM RISK ANALYSIS (SRA). ¿THE DHR WAS REVIEWED AND NO ISSUES RELATING THE FAILURE MODE WERE NOTED. THE INVOLVED UNIT MET MANUFACTURER SPECIFICATIONS AT THE TIME OF RELEASE. ¿THE SERVICE HISTORY FOR THIS UNIT WAS REVIEWED FOR THE PAST 6 MONTHS (01/10/2015 TO 07/09/2015) AND TRENDING WAS NOT EXCEEDED. ¿THE FMEA REVEALED THE RISK PRIORITY NUMBER (RPN) IS AT AN ACCEPTABLE LEVEL. ¿THE SRA SHOWS THE RISK FOR EXPOSURE TO TOXIC OR CORROSIVE MATERIAL TO BE "LOW." THE ASSIGNABLE CAUSE OF THE HAZE/MIST/VAPOR IS THE LOOSE OIL RETURN VALVE. THE FIELD SERVICE ENGINEER TIGHTENED THIS PART AND CONFIRMED THE STERRAD® 100NX WAS RESTORED TO PROPER FUNCTION AFTER SERVICE. THE ISSUE WAS RESOLVED AT THE CUSTOMER FACILITY. ASP WILL CONTINUE TO TRACK AND TREND THIS ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN EVENT OF A ¿SMOKE/HAZE¿ EMITTING FROM THE STERRAD® 100NX STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. THE CUSTOMER WAS ADVISED TO TURN THE UNIT OFF. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ON SITE. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496951 STERRAD 100NX STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1