BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDGRAPHICS PFDX

    MDR report key: 203476 · Received December 23, 1998

    Report

    Report Number
    MW1015286
    Event Type
    Malfunction
    Date Received
    December 23, 1998
    Date of Event
    August 19, 1998
    Report Date
    November 9, 1998
    Manufacturer
    MEDICAL GRAPHICS CORPORATION
    Product Code
    BZM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A COMPLETE PULMONARY FUNCTION TEST, THE DEMAND VALVE MALFUNCTIONED, ALLOWING TANK PRESSURE TO BE DELIVERED TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDGRAPHICS PFDX PULMONARY FUNCTION TEST EQUIPMENT BZM MEDICAL GRAPHICS CORPORATION DEMAND VALVE - G500 *

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR