BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 200 STERILIZATION SYSTEM SINGLE-DOOR UNIT

    MDR report key: 1060781 · Received June 12, 2008

    Report

    Report Number
    2084725-2008-00287
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 22, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FSE PERFORMED PUMPDOWN, AND LET THE VACUUM PUMP FOR 30 MINS. THERE WERE NO MIST OR ODOR OBSERVED. THE FSE REPLACED THE OIL MIST FILTER. THE SYSTEM WAS FOUND TO MEET MFG SPECIFICATIONS. THIS ISSUE HAS BEEN ADDRESSED WITH A CUSTOMER LETTER RELATED TO CORRECTION & REMOVAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS ODOR COMING FROM THE UNIT. THE CUSTOMER ALSO STATED THAT THERE WERE NO PHYSICAL COMPLAINTS REPORTED. THE ASP FIELD SERVICE ENGINEER WENT TO THE FACILITY TO ASSESS THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD 200 STERILIZATION SYSTEM SINGLE-DOOR UNIT STERILIZER MLR ADVANCED STERILIZATION PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA