BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDGRAPHICS PROFILER SERIES SYSTEM

    MDR report key: 1649718 · Received March 30, 2010

    Report

    Report Number
    MW5015354
    Event Type
    Injury
    Date Received
    March 30, 2010
    Date of Event
    December 18, 2009
    Report Date
    March 23, 2010
    Manufacturer
    MEDICAL GRAPHICS CORP.
    Product Code
    JAX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS HAVING A PULMONARY FUNCTION TEST. WHILE ATTEMPTING TO PROCEED WITH THE TEST ON INHALATION, THE SCREEN CONTAINED IN THE PREVENT PNEUMOTACH DISLODGED AND WAS SWALLOWED BY THE PT. THE SCREEN FROM THE PREVENT WAS LODGED IN THE PT'S ESOPHAGUS. DATES OF USE: LAST DATE USED (B) (6) 2009. DIAGNOSIS OR REASON FOR USE: EQUIPMENT USED WITH PULMONARY FUNCTION TESTING. CLEANED BY STAFF IN PULMONARY FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDGRAPHICS PROFILER SERIES SYSTEM PRE-VENT PNEUMOTACH-A PART OF THE PT CIRCUIT INSTALLATION-ME JAX MEDICAL GRAPHICS CORP.
    2 MEDGRAPHICS ELITE SERIES PLETHYSMOGRAPH PRE-VENT PNEUMOTACH-A PART OF THE PT CIRCUIT INSTALLATION-MEASURES MOUTH PRESSUR JAX MEDICAL GRAPHICS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention