BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD/FLUID WARMER

    MDR report key: 2143735 · Received June 3, 2011

    Report

    Report Number
    1313850-2011-00134
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    STRYKER CORP. DBA GAYMAR
    Product Code
    BSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF FILING DATE, CUSTOMER HAS NOT RETURNED PRODUCT FOR EVAL. WITHOUT BEING ABLE TO EVALUATE UNIT, WORST CASE SCENARIO IS ASSUMED AND THEREFORE MEDWATCH WILL BE FILED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A F/U REPORT WILL BE ISSUED AS NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE UNIT HAS A BROKEN CLAMP AND SWIVEL HEAD SCREW. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1