BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 200 STERILIZATION SYSTEM SINGLE-DOOR UNIT WITH STAINLESS STEEL EXTERIOR

    MDR report key: 1140665 · Received August 28, 2008

    Report

    Report Number
    2084725-2008-00539
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    August 2, 2008
    Report Date
    August 2, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K030429
    Removal / Correction Number
    Z-1630-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER, OIL MIST - CAPITAL EQUIPMENT, THE UNIT WAS EVALUATED AT THE CUSTOMER SITE. THE FSE FOUND THE OIL MIST LEAK COMING FROM THE OIL MIST FILTER. THE FSE REPLACED THE OIL MIST FILTER ELEMENT AND THE SYSTEM MET SPECIFICATIONS.

    Description of Event or Problem · 1

    THE ASP FIELD SERVICE ENGINEER (FSE) FOUND OIL MIST COMING FROM THE CUSTOMER'S UNIT. 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 SINGLE-DOOR UNIT WITH STAINLESS STEEL EXTERIOR NONE MLR ADVANCED STERILIZATION PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA