BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONARY FUNCTION LABORATORY

    MDR report key: 56196 · Received September 24, 1996

    Report

    Report Number
    2050001-1996-90004
    Event Type
    Malfunction
    Date Received
    September 24, 1996
    Date of Event
    September 10, 1996
    Report Date
    September 23, 1996
    Manufacturer
    SENSOR MEDICS CORP.
    Product Code
    BZC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE VACUUM PUMP FOR THE NITROGEN ANALYZER USED IN THE MODEL 2200 WAS MAKING A LOUD GRINDING NOISE AND A BURNING SMELL WAS NOTICED. THERE WERE NO INJURIES OR HARM CAUSED TO ANYONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONARY FUNCTION LABORATORY PULMONARY TESTING SYSTEM BZC SENSOR MEDICS CORP. 2200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA