BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZER

    MDR report key: 5997267 · Received October 4, 2016

    Report

    Report Number
    2084725-2016-00583
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Date of Event
    September 10, 2016
    Report Date
    September 10, 2016
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD (DHR), FUNCTIONAL ANALYSIS 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 SRA SHOWS THE RISK FOR EXPOSURE TO TOXIC OR CORROSIVE MATERIAL TO BE "LOW." THE OIL MIST FILTER CARTRIDGE AND VACUUM PUMP OIL WERE NOT RETURNED FOR EVALUATION. THE ASSIGNABLE CAUSE OF THE ODOR/SMELLS IS THE OIL MIST FILTER CARTRIDGE AND VACUUM PUMP OIL. 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.

    Additional Manufacturer Narrative · 1

    THE CORRECT BRAND NAME IS STERRAD(TM)NX SYS-JAPANES. THE CORRECT CATALOG NUMBER IS 00-10033-2-002, THE CORRECT SERIAL NUMBER IS (B)(4). A FIELD SERVICE ENGINEER WAS DISPATCHED TO CUSTOMER SITE. THE VACUUM PUMP OIL AND OIL MIST FILTER WERE REPLACED TO RESOLVE THE ODOR/SMELLS ISSUE. UNIT MEETS SPECIFICATIONS AND WAS RETURNED TO SERVICE ON 09/10/2016.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN ODOR 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
    647341 STERRAD NX STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1