BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 200 STERILIZATION SYSTEM

    MDR report key: 1040854 · Received May 9, 2008

    Report

    Report Number
    2084725-2008-00164
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 18, 2008
    Report Date
    April 18, 2008
    Manufacturer
    YAMATO LAB-TECH CO., LTD
    Product Code
    MLR
    PMA / PMN Number
    K030429
    Removal / Correction Number
    Z-1630-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CAPITAL EQUIPMENT, FSE WENT TO THE FACILITY. THE FSE REPLACED THE OIL MIST FILTER AND THE CATALYTIC CONVERTER BECAUSE THERE WAS "OIL MIST" COMING OUT OF IT. HE VERIFIED THAT NO OIL MIST WAS COMING OUT OF IT. HE VERIFIED THAT THE SYSTEM MET MFR SPECIFICATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BURNING SMELL COMING FROM THE UNIT WHEN IT WAS RUNNING. THEY STATED THAT THE SMELL WOULD OCCUR DURING THE "INJECTION PHASE". THE UNIT WAS NOT CANCELING. THE CUSTOMER STATED THAT THERE WERE NO PHYSICAL COMPLAINTS REPORTED. THE ASP FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY TO REPAIR THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD 200 STERILIZATION SYSTEM STERILIZER MLR YAMATO LAB-TECH CO., LTD 10201 NA

    Patients

    Seq Age Sex Outcome Treatment
    1