BEUDAMED
    FDA Adverse Event Summary report: N

    VOLDYNE VOLUMETRIC EXERCISER

    MDR report key: 12413 · Received March 30, 1994

    Report

    Report Number
    MW1001335
    Date Received
    March 30, 1994
    Report Date
    March 18, 1994
    Manufacturer
    SHERWOOD MEDICAL CO.
    Product Code
    BZG
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    PRODUCT IS DESIGNED TO MEASURE INHALED VOLUME. WHEN USING DEVICE WITH OPTIMUM INSPIRATORY FLOW, THE DEVICE DOES NOT READ ANY VOLUME. THIS RESULTS IN A VERY FALSE LOW READING AND MAY RESULT IN PTS GETTING ADD'L THERAPY THEY DIDN'T REALLY NEED. EVENT OCCURRED WEEK OF 3/14-18.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOLDYNE VOLUMETRIC EXERCISER BZG SHERWOOD MEDICAL CO. 300241, 300244, 300051

    Patients

    Seq Age Sex Outcome Treatment
    1 *