BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCENTIVE SPIROMETER

    MDR report key: 1740396 · Received June 14, 2010

    Report

    Report Number
    3004365956-2010-00072
    Event Type
    Malfunction
    Date Received
    June 14, 2010
    Date of Event
    May 16, 2010
    Report Date
    May 18, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BWF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT. THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED AS: THE ONE WAY VALVE BROKE APART WHILE THE DEVICE WAS BEING USED BY A PT. THE VALVE WAS SUCKED INSIDE OF THE MOUTHPIECE OF THE DEVICE. THE VALVE WAS REMOVED FROM THE MOUTHPIECE BEFORE IT REACHED THE PT'S MOUTH. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INCENTIVE SPIROMETER INCENTIVE SPIROMETER BWF TELEFLEX MEDICAL NA 02D1000692

    Patients

    Seq Age Sex Outcome Treatment
    1