BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON VOLDYNE 500 VOLUMETRIC EXERCISER

    MDR report key: 3131262 · Received May 23, 2013

    Report

    Report Number
    3003898360-2013-00206
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 9, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. DOCUMENT REVIEW OF FMEA (PRODUCT/PROCESS) WAS CONDUCTED AND NO CHANGES REQUIRED. THE COMPLAINT CANNOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THE DEFECT REPORTED AND A CORRECTIVE ACTION TAKEN. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE DEVICE IS LEAKING DURING USE. PER THE CUSTOMER, IT APPEARS THAT THE AIR IS LEAKING FROM THE TUBING WHICH DOESN'T ALLOW THE DEVICE TO FUNCTION AS INTENDED. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229327 HUDSON VOLDYNE 500 VOLUMETRIC EXERCISER INCENTIVE SPIROMETER BWF TELEFLEX MEDICAL 01B1000158

    Patients

    Seq Age Sex Outcome Treatment
    1