BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE MONITORING KIT

    MDR report key: 1781673 · Received July 28, 2010

    Report

    Report Number
    1781673
    Event Type
    Malfunction
    Date Received
    July 28, 2010
    Date of Event
    July 17, 2010
    Report Date
    July 28, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ANESTHESIA TECHNICIAN REPORTS UPON OPENING A PRESSURE MONITORING KIT THE DEVICE WAS FOUND TO HAVE COME APART WITHIN THE PACKAGING. NO INJURY TO PATIENT AS DEFECT WAS FOUND PRIOR TO USE. NEW KIT OBTAINED AND USED WITH NO FURTHER CONCERNS. THIS KIT IS A CUSTOM KIT MADE FOR OUR FACILITY.IT IS MY UNDERSTANDING A NEW CUSTOM KIT WAS CREATED FOR OUR FACILITY AS THIS WAS NOT THE FIRST INCIDENT OF THIS DEFECT, ALTHOUGH IT WAS THE FIRST REPORTED TO OUR OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESSURE MONITORING KIT TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR DRS EDWARDS LIFESCIENCES * 58857993

    Patients

    Seq Age Sex Outcome Treatment
    1 *