BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYCLESURE BIOLOGICAL INDICATOR

    MDR report key: 1111854 · Received August 13, 2008

    Report

    Report Number
    2084725-2008-00514
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 24, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FRC
    PMA / PMN Number
    K994055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAPITAL EQUIPMENT, UNIT EVALUATED AT THE FACILITY. THE SERVICE ENGINEER (FSE) WENT TO THE FACILITY AND FOUND THAT UNIT WORKED TO SPECIFICATIONS.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED A "POSITIVE REACTION" WITH CYCLESURE. THE CUSTOMER REPORTED THAT THE LOAD WAS NOT RECALLED. THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO CHECK THE MACHINE PERFORMANCE AFTER THE POSITIVE REACTION REPORT. THE CUSTOMER DID NOT PROVIDE INFORMATION REGARDING POTENTIAL PATIENT INJURY RELATED TO THE UNRECALLED ITEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYCLESURE BIOLOGICAL INDICATOR NONE FRC ADVANCED STERILIZATION PRODUCTS NA 12181Z

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK STERRAD 200 STERILIZATION SYSTEM CATALOG #10201