BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON VOLDYNE 5000 VOLUMETRIC EXERCISER

    MDR report key: 5096932 · Received September 23, 2015

    Report

    Report Number
    3003898360-2015-00666
    Event Type
    Malfunction
    Date Received
    September 23, 2015
    Date of Event
    September 14, 2015
    Report Date
    September 14, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. THE DEVICE HISTORY RECORD INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. A DOCUMENT ASSESSMENT (FMEA) WAS CONDUCTED AND NO CHANGES REQUIRED. CORRECTIVE ACTIONS CANNOT BE ESTABLISHED SINCE IT IS NECESSARY TO RECEIVE THE PHYSICAL SAMPLE TO PERFORM A PROPER INVESTIGATION AND CONFIRM THE ALLEGED DEFECT. AT THIS TIME SINCE THE SAMPLE IS NOT AVAILABLE IT IS NOT POSSIBLE TO DETERMINE THE SOURCE OF THE DEFECT REPORTED. CUSTOMER COMPLAINT CANNOT BE CONFIRMED SINCE THE DEVICE SAMPLE IS NOT AVAILABLE TO PERFORM A PROPER INVESTIGATION AND DETERMINE THE ROOT CAUSE. IF THE DEVICE SAMPLE BECOMES AVAILABLE AT A LATER DATE, THIS COMPLAINT WILL BE UPDATED ACCORDINGLY. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE DEVICE IS LEAKING DURING TREATMENT. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627406 HUDSON VOLDYNE 5000 VOLUMETRIC EXERCISER INCENTIVE SPIROMETER BWF TELEFLEX MEDICAL 73D1500192

    Patients

    Seq Age Sex Outcome Treatment
    1