BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONARY FUNCTION LABORATORY

    MDR report key: 53326 · Received November 22, 1996

    Report

    Report Number
    2050001-1996-00027
    Event Type
    Malfunction
    Date Received
    November 22, 1996
    Date of Event
    October 30, 1996
    Report Date
    November 20, 1996
    Manufacturer
    SENSOR MEDICS CORP.
    Product Code
    BZC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE USER REPORTED A BURNING SMELL AFTER THE MODEL 2400 WAS TURNED ON. THERE WERE NO PTS INVOLVED AND NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONARY FUNCTION LABORATORY PULMONARY FUNCTION TESTER BZC SENSOR MEDICS CORP. 2400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA