BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PF/V-MAX ENCORE SENSORMEDICS PULMONARY FUNCTION TESTING SYSTEM

    MDR report key: 2016325 · Received March 7, 2011

    Report

    Report Number
    MW5019714
    Event Type
    Malfunction
    Date Received
    March 7, 2011
    Date of Event
    February 25, 2011
    Report Date
    March 3, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    BTY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING DIAGNOSTIC TEST IN WHICH PT WAS BLOWING ON PLASTIC MOUTHPIECE, THE PLASTIC DIAPHRAGM BURST UNDER PRESSURE FROM MACHINE. PT WAS FRIGHTENED, BUT NOT HARMED. DESCRIBED BY STAFF AS A LOUD GUNSHOT, THE TEST WAS CANCELED. SERVICE CALLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PF/V-MAX ENCORE SENSORMEDICS PULMONARY FUNCTION TESTING SYSTEM FLOW SENSOR DIAPHRAGM BTY CAREFUSION CORP. 62 JW

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR