BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WINDSURFER

    MDR report key: 1351017 · Received March 13, 2009

    Report

    Report Number
    1351017
    Event Type
    Malfunction
    Date Received
    March 13, 2009
    Date of Event
    February 23, 2009
    Report Date
    March 13, 2009
    Manufacturer
    MCKESSON INFORMATION SOLUTIONS, LLC
    Product Code
    MWI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    WHILE DOCTOR WAS PERFORMING A VASODILATOR STUDY, THE MCKESSON WINDSURFER MONITORING SYSTEM DID NOT PERFORM ACCURATE COMMANDS IN ORDER TO OBTAIN PERTINENT INFORMATION. WHILE TRYING TO MEASURE PRESSURES, THE CARDIAC OUTPUT WOULD NOT FUNCTION PROPERLY AND THE SYSTEM FROZE. THIS HAS HAPPENED NUMEROUS TIMES IN THE PAST AND MCKESSON AND ARE AWARE OF THE PROBLEM. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WINDSURFER MONITORING SYSTEM, HEMODYNAMIC MWI MCKESSON INFORMATION SOLUTIONS, LLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR