BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZER

    MDR report key: 4852299 · Received June 17, 2015

    Report

    Report Number
    2084725-2015-00129
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    June 12, 2015
    Report Date
    June 15, 2015
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K042116
    Removal / Correction Number
    Z-0744-0746-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PART REPLACED: OIL MIST FILTER. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD (DHR), FAILURE MODE AND EFFECTS ANALYSIS (FMEA), SYSTEM RISK ANALYSIS (SRA) AND FUNCTIONAL ANALYSIS. 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 FMEA REVEALED THE RISK PRIORITY NUMBER (RPN) IS AT AN ACCEPTABLE LEVEL. THE SRA SHOWS THE RISK FOR EXPOSURE TO ODOR/SMELLS TO BE "LOW." THE CATALYTIC CONVERTER WAS RETURNED AND TESTED. THE REASON FOR THE RETURN OF THE CATALYTIC CONVERTER WAS CONFIRMED. THE OIL MIST FILTER WAS RETURNED AND TESTED. THE REASON FOR THE RETURN OF THE OIL MIST FILTER WAS CONFIRMED. THE VACUUM PUMP WAS NOT RETURNED FOR FUNCTIONAL EVALUATION. THE ISSUE WAS RESOLVED AT THE CUSTOMER FACILITY. ASP WILL CONTINUE TO TRACK AND TREND THIS ISSUE.

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER WAS DISPATCHED TO CUSTOMER SITE. ODOR/SMELL WAS CONFIRMED. THE CATALYTIC DECOMP FILTER AND VACUUM PUMP WERE REPLACED. UNIT MEETS SPECIFICATIONS AND WAS RETURNED TO SERVICE ON 06/16/2015.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN EVENT OF AN "ODOR/SMELL" EMITTING FROM THE STERRAD® NX STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. THE CUSTOMER WAS ADVISED TO TURN THE UNIT OFF AND CLEAR THE AREA UNTIL THE ODOR IS GONE. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. 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
    395851 STERRAD NX STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1