BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 200 STERILIZATION SYSTEM

    MDR report key: 1003327 · Received February 27, 2008

    Report

    Report Number
    2084725-2008-00041
    Event Type
    Malfunction
    Date Received
    February 27, 2008
    Date of Event
    January 31, 2008
    Report Date
    January 31, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE REPLACED THE OIL MIST FILTER. HE RAN AN EMPTY TEST CYCLE, THE UNIT MET SPECIFICATIONS.

    Description of Event or Problem · 1

    WHILE AT THE SITE REPAIRING THE UNIT FOR "LOW PRESSURE IN INJECTION", THE ASP FIELD SERVICE ENGINEER (FSE) FOUND A SMALL AMOUNT OF OIL MIST COMING FROM THE VACUUM PUMP EXHAUST FILTER. THE CUSTOMER STATED THAT THERE WERE NO PHYSICAL COMPLAINTS RELATED TO THE OIL MIST. 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 10201-001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA