BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 200 STERILIZATION SYSTEM

    MDR report key: 1003399 · Received February 21, 2008

    Report

    Report Number
    2084725-2008-00031
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 25, 2008
    Report Date
    January 25, 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
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE WENT TO THE FACILITY AND WAS UNABLE TO RECREATE THE OIL MIST. HE CHANGED THE OIL MIST FILTER AND TESTED THE UNIT. THE UNIT MET SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAZE/OIL MIST COMING FROM THE UNIT. THE CUSTOMER STATED THAT THERE WERE NO PHYSICAL COMPLAINTS RELATED TO THE OIL MIST. THE ASP FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY AND 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