BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPITAL BLOOD/FLUID WARMER

    MDR report key: 5004621 · Received August 14, 2015

    Report

    Report Number
    0001831750-2015-00394
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Date of Event
    July 10, 2015
    Report Date
    July 20, 2015
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    KZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT MADE AVAILABLE FOR INVESTIGATION. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GROUND RESISTANCE WAS HIGH. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GROUND RESISTANCE WAS HIGH. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539623 CAPITAL BLOOD/FLUID WARMER DEVICE, WARMING. BLOOD AND PLASMA KZL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1