BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON RESPIFLO 2500 VOLUMETRIC EXERCISER

    MDR report key: 2489757 · Received March 5, 2012

    Report

    Report Number
    3003898360-2012-00048
    Event Type
    Malfunction
    Date Received
    March 5, 2012
    Report Date
    February 13, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE REC'D BY MFR, BUT INVESTIGATION IS INCOMPLETE AT TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: "COMPLAINT ALLEGES THAT THE MESH PART OF THE MOUTHPIECE WAS OCCLUDED IN PLACES WITH SOMETHING WHITE. COMPLAINT STATES THAT THE TROUBLE WAS DETECTED DURING USE. NO PT HARM REPORTED." NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON RESPIFLO 2500 VOLUMETRIC EXERCISER VOLUMETRIC EXERCISER BWF TELEFLEX MEDICAL 01C1100411

    Patients

    Seq Age Sex Outcome Treatment
    1