BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD® NX STERILIZER

    MDR report key: 7283552 · Received February 20, 2018

    Report

    Report Number
    2084725-2018-00531
    Event Type
    Malfunction
    Date Received
    February 20, 2018
    Date of Event
    December 8, 2017
    Report Date
    January 23, 2018
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K994055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CATALOG # CORRECTION 10033 TO 10033002. PMA/510(K) CORRECTION FROM K042116 TO K994055. DEVICE MANUFACTURE DATE CORRECTION FROM 9/20/2014 TO 9/22/2014 A FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER SITE. THE VACUUM PUMP, CATALYTIC CONVERTER AND OIL MIST FILTER WERE REPLACED TO RESOLVE THE SMOKE/HAZE ISSUE. UNIT MEETS SPECIFICATIONS AND WAS RETURNED TO SERVICE. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD (DHR), TRENDING ANALYSIS OF THE SMOKE/HAZE ISSUE, 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. TRENDING ANALYSIS OF THE SMOKE/HAZE ISSUE WAS REVIEWED FROM JULY 2017 TO JANUARY 2018 AND NO SIGNIFICANT TREND WAS OBSERVED. THE SRA SHOWS THE RISK FOR EXPOSURE TO TOXIC OR CORROSIVE MATERIAL TO BE "LOW." THE CATALYTIC CONVERTER WAS RETURNED AND TESTED. THE CATALYTIC CONVERTER EXHIBITED NO SMOKE, HAZE OR MIST. THE REASON FOR RETURN OF THE CATALYTIC CONVERTER WAS NOT CONFIRMED. THE OIL MIST FILTER WAS RETURNED AND TESTED. THE OIL MIST FILTER EXHIBITED NO SMOKE OR HAZE OR MIST. THE REASON FOR RETURN OF THE OIL MIST FILTER WAS NOT CONFIRMED. THE ASSIGNABLE CAUSE OF THE SMOKE/HAZE ISSUE IS LIKELY DUE TO THE OIL MIST FILTER, CATALYTIC CONVERTER AND VACUUM PUMP. THE FIELD SERVICE ENGINEER REPLACED THESE PARTS AND CONFIRMED THE STERRAD® NX WAS RESTORED TO PROPER FUNCTION AFTER SERVICE. THE ISSUE WAS RESOLVED AT THE CUSTOMER FACILITY. ASP WILL CONTINUE TO TRACK AND TREND THIS ISSUE. ASP COMPLAINT REF #: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED INDICATING THE UNIT HAS BEEN RETURNED TO AN ASP SERVICE CENTER FOR REPAIR. HOWEVER, NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME REGARDING THE REPAIR. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED ¿SMOKE¿ WAS EMITTING FROM THE STERRAD NX STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. 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
    127583 STERRAD® NX STERILIZER STERRAD® EQUIPMENT MLR ADVANCED STERILIZATION PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1