BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 237110 · Received August 19, 1999

    Report

    Report Number
    MW1016971
    Event Type
    Malfunction
    Date Received
    August 19, 1999
    Report Date
    August 17, 1999
    Manufacturer
    SENSOR MEDICS CORP.
    Product Code
    BZM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SENSORMEDICS VMAX 229 PULMONARY FUNCTION SYSTEM CONSISTENTLY UNDERESTIMATES THE LUNG VOLUME DETERMINATION IN PTS WITH COPD. SYSTEM USES NITROGEN WASHOUT METHOD TO MEASURE LUNG VOLUME. REPLACED MODULES AND RECEIVED SOFTWARE UPGRADE WITH NO CHANGE IN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS PULMONARY FUNCTION ANALYZER BZM SENSOR MEDICS CORP. VMAX 229 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other