BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON VOLDYNE 2500 VOLUMETRIC EXERCISER

    MDR report key: 3243097 · Received July 18, 2013

    Report

    Report Number
    3003898360-2013-00306
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 28, 2013
    Report Date
    July 4, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PICTURES PROVIDED FROM THE CUSTOMER ARE NOT ENOUGH TO CONFIRM THE FAILURE MODE, SAMPLE IS REQUIRE TO CONDUCT AN EVALUATION. A DIMENSIONAL AND FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. PER DHR (DEVICE HISTORY RECORD) REVIEW THE PRODUCT VOLDYNE 2500 VOLUMETRIC EXERCISER, LOT # 01D1300012 WAS MANUFACTURED ON 04/16/2013. THE DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. DOCUMENT (FMEA) ASSESSMENT WAS CONDUCTED AND NO CHANGES WERE REQUIRED. THE PICTURES PROVIDED FROM THE CUSTOMER ARE NOT ENOUGH TO CONFIRM THE FAILURE MODE, THE COMPLAINT CANNOT BE CONFIRMED AND A CONCLUSIVE ROOT CAUSE CANNOT BE DETERMINED SINCE THE SAMPLE WAS NOT AVAILABLE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: THE PATIENT (END-USER) ALLEGES THAT THE YELLOW PLUNGER OF HIS VOLDYNE VOLUMETRIC EXERCISER IS JAMMING, OR SEIZING INTO PLACE AT THE REST POSITION. THE END-USER REPORTS THAT HE MUST EXPAND MUCH MORE OF A BREATH THAN HE SHOULD TO DISLODGE THE PLUNGER TO MEET PRESCRIBED VOLUME. PATIENT CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335558 HUDSON VOLDYNE 2500 VOLUMETRIC EXERCISER INCENTIVE SPIROMETER BWF TELEFLEX MEDICAL 01D1300012

    Patients

    Seq Age Sex Outcome Treatment
    1