BEUDAMED
    FDA Adverse Event Other Summary report: N

    VMAX 22

    MDR report key: 312575 · Received January 10, 2001

    Report

    Report Number
    2050001-2001-00005
    Event Type
    Other
    Date Received
    January 10, 2001
    Report Date
    January 10, 2001
    Manufacturer
    SENSOR MEDICS CORP
    Product Code
    BTY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER CLEANING THE BREATHING VALVE OF THE VMAX 22, THE CUSTOMER REPORTED OBSERVING FLUID BEING TRAPPED INSIDE A CLOSED-OFF CAVITY IN THE VALVE. THERE WERE NO PTS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1352 VMAX 22 PULMONARY TESTING SYSTEM BTY SENSOR MEDICS CORP VMAX 22 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA