BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON VOLDYNE 2500 VOLUMETRIC EXCERCISER

    MDR report key: 3123701 · Received May 14, 2013

    Report

    Report Number
    3003898360-2013-00193
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, DIMENSIONAL AND FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. DOCUMENT REVIEW ((B)(4) - PRODUCT/PROCESS) ASSESSED AND NO CHANGES REQUIRED. THE COMPLAINT CAN NOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER REPORTS THAT THE PRODUCT IS NOT WORKING PROPERLY. THE YELLOW FLOW CUP WAS NOT OPERATING AS IT SHOULD. ANOTHER VOLDYNE EXERCISER WAS OBTAINED FOR PATIENT USE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211841 HUDSON VOLDYNE 2500 VOLUMETRIC EXCERCISER INCENTIVE SPIROMETER BWF TELEFLEX MEDICAL 01A1300453

    Patients

    Seq Age Sex Outcome Treatment
    1