BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPITAL BLOOD/FLUID WARMER

    MDR report key: 3875055 · Received June 16, 2014

    Report

    Report Number
    0001831750-2014-03067
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    February 6, 2014
    Report Date
    February 6, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    KZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY REPAIR WORK ORDER THAT THE GROUNDING PATH WAS COMPROMISED. 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
    353239 CAPITAL BLOOD/FLUID WARMER DEVICE, WARMING. BLOOD AND PLASMA KZL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1