BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONARY/METABOLIC SYSTEM (VMAX SERIES)

    MDR report key: 56516 · Received December 6, 1996

    Report

    Report Number
    2050001-1996-00042
    Event Type
    Malfunction
    Date Received
    December 6, 1996
    Date of Event
    November 14, 1996
    Report Date
    December 6, 1996
    Manufacturer
    SENSORMEDICS CORP.
    Product Code
    BZC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE TESTING A PT ON THE VMAX299, SMOKE WAS OBSERVED COMING OUT OF THE BACK RIGHT CORNER OF THE ANALYZER MODULE. THERE WERE NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONARY/METABOLIC SYSTEM (VMAX SERIES) PULMONARY/METABOLIC TESTER BZC SENSORMEDICS CORP. VMAX 299 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO