BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD/FLUID WARMER

    MDR report key: 2412132 · Received January 5, 2012

    Report

    Report Number
    1313850-2012-00005
    Event Type
    Malfunction
    Date Received
    January 5, 2012
    Date of Event
    December 7, 2011
    Report Date
    December 7, 2011
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT HAS NOT YET BEEN RETURNED FOR EVAL; FOLLOW-UP REPORT WILL BE ISSUED AS NECESSARY BASED UPON INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT HAS A FRAYED POWER CORD. NO PT 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