BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100NX STERILIZER

    MDR report key: 2862959 · Received December 10, 2012

    Report

    Report Number
    2084725-2012-00087
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K071385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INVESTIGATION, THIS ODOR/SMELLS COMPLAINT WAS THE RESULT OF A NON-VACUUM SYSTEM VAPOR RELATED ODOR. UPON RETURN, THE LFPS2 POWER SUPPLY MODULE FAILED FUNCTIONAL TESTING. AS A RESULT, THIS COMPLAINT IS DEEMED NOT REPORTABLE BECAUSE THERE IS NO SERIOUS INJURY TRIGGER RELATED TO ELECTRICAL COMPONENTS IN STERRAD® STERILIZERS TO REPORT A MALFUNCTION AND A SERIOUS INJURY OR DEATH IS NOT LIKELY WERE THIS MALFUNCTION TO REOCCUR.

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER SITE. ODOR/SMELL WAS CONFIRMED. A PM2 WAS PERFORMED AND THE LFPS-POWER SUPPLY, (B)(4) WAS REPLACED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN EVENT OF ODOR EMITTING FROM THE STERRAD 100NX. THERE WAS NO REPORT OF HUMAN REACTION. THE UNIT WAS TURNED OFF AND 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 EVENT DATED (B)(6) 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1