BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 200 STERILIZATION SYSTEM

    MDR report key: 1003398 · Received February 21, 2008

    Report

    Report Number
    2084725-2008-00030
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 24, 2008
    Report Date
    January 24, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE CHANGED THE OIL MIST FILTER AND TESTED THE UNIT. THE UNIT MET SPECS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ODOR/SMELL COMING FROM THE UNIT. THE ASP FIELD SVC ENGINEER (FSE) ASSESSED THE UNIT AND FOUND THE OIL MIST FILTER "SMOKING". THE CUSTOMER STATED THAT THERE WERE NO PHYSICAL COMPLAINTS REPORTED. THE FSE REPAIRED 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 NA