BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON INCENTIVE SPIROMETER

    MDR report key: 2160879 · Received June 16, 2011

    Report

    Report Number
    3004365956-2011-00247
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    March 25, 2011
    Report Date
    June 13, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BWF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE DEVICE EVAL AND INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE MOUTH PIECE OF THE INCENTIVE SPIROMETER PARTIALLY SEPARATED BY TEARING. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON INCENTIVE SPIROMETER INCENTIVE SPIROMETER BWF TELEFLEX MEDICAL NA 02H1000630

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK