BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B/F WARM SET W/48" EXT CE

    MDR report key: 2974684 · Received January 18, 2013

    Report

    Report Number
    1313850-2013-90008
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ADDED THAT THE DISPOSABLE INSERT WOULD NOT BE AVAILABLE FOR INVESTIGATION. THE REASON FOR THE SERIALIZATION STARTING WITH 90XXX IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKERS ELECTRONIC COMPLAINT SYSTEMS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DISPOSABLE INSERT HAD SPLIT WHILE BEING USED WITH THE FLUID WARMER. THE CUSTOMER REPORTED THAT THE THEATRE STAFF HAD DISCONNECTED THE FLUID WARMER AND USED A NEW INSERT. THE CUSTOMER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES FOR THE PT. THE CUSTOMER ADDED THAT THE DISPOSABLE INSERT WOULD NOT BE AVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28535 B/F WARM SET W/48" EXT CE CASSETTE LGZ STRYKER CORP DBA GAYMAR D25310CE M2812 #3

    Patients

    Seq Age Sex Outcome Treatment
    1