BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 1191297 · Received September 26, 2008

    Report

    Report Number
    2084725-2008-00595
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 3, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K991999
    Removal / Correction Number
    Z-1628-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER, OIL MIST, CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FSE REPLACED THE VACUUM PUMP OIL AND FILTER. THE FSE VERIFIED SYSTEM MEETS MANUFACTURERS SPECIFICATIONS. THE FSE RAN AN EMPTY CHAMBER TEST OK. CONCLUSION: OTHER - CUSTOMER LETTER WAS SENT TO ALL STERRAD CUSTOMERS TO REINFORCE THE IMPORTANCE OF CANCELLING THE CYCLE, LEAVING THE ROOM AND DISCONTINUE USE OF THE UNIT UNTIL THE UNIT IS REPAIRED, IF THE MIST ISSUE OCCURS. A USER GUIDE EXCERPT THAT ADDED A WARNING WAS SENT WITH THE CUSTOMER LETTER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OIL MIST/HAZE. THERE WERE NO REPORTS OF PHYSICAL COMPLAINTS RELATED TO THE MIST. THE ASP FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY TO ASSESS THE UNIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA