BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON VOLDYNE2500 INCENTIVE SPIROMETER

    MDR report key: 3896471 · Received May 16, 2014

    Report

    Report Number
    3003898360-2014-00298
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 25, 2014
    Manufacturer
    TELEFLEX
    Product Code
    BWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. AN ASSESSMENT ((B)(4)) WAS CONDUCTED AND NO CHANGES WERE REQUIRED. THE SAMPLE WAS NOT RETURNED FOR EVALUATION, THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. IF THE SAMPLE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: THE YELLOW INDICATOR CUP WAS STICKING ON THE DOWNWARD MOVEMENT. THE DEVICE WOULD NOT REFLECT THE PATIENT'S ACCURATE BREATH FORCE WHEN STARTING A NEW BREATHING CYCLE. THERE WAS NO HARM TO THE PATIENT. THE PATIENT CONDITION WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294601 HUDSON VOLDYNE2500 INCENTIVE SPIROMETER INCENTIVE SPIROMETER BWF TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1