BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD/FLUID WARMER

    MDR report key: 2243264 · Received September 1, 2011

    Report

    Report Number
    1313850-2011-00373
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 2011
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FLUID WARMER'S IV POLE CLAMP WAS BROKEN SO THE UNIT COULD NO LONGER BE SECURED TO AN IV POLE. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOOD/FLUID WARMER FLUID WARMER LGZ STRYKER CORP DBA GAYMAR FW600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1