BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S8 AUTOSET TEIJIN

    MDR report key: 4913193 · Received July 9, 2015

    Report

    Report Number
    3004604967-2015-00250
    Event Type
    Injury
    Date Received
    July 9, 2015
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K033841
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE HAS NOT BEEN RETURNED TO RESMED FOR INVESTIGATION. IT WAS REPORTED THAT THS PT RECENTLY HAD LUNG SURGERY AND WAS USING THE DEVICE POST SURGERY. A CLINICAL OPINION WAS PROVIDED BY RESMED'S CHIEF MEDICAL OFFICER IN REGARDS TO THIS REPORTED ISSUE. PER THE MEDICAL OPINION, "PNEUMOTHORAX IS A KNOWN POTENTIAL RISK OF PAP THERAPY PARTICULARLY IN PTS WHO MAY BE PRONE TO DEVELOPING AIR LEAKS BETWEEN THE AIRWAYS AND PLEURA. IT IS MENTIONED IN THE 'WARNINGS' IN THE USER INSTRUCTIONS FOR RESMED PAP PRODUCTS. A PT WHO HAS RECENTLY HAD A LOBECTOMY IS AT HIGH RISK OF DEVELOPING A PNEUMOTHORAX POST OPERATIVELY AND THIS RISK WOULD BE INCREASED WITH USE OF PAP. THIS INCREASED RISK WOULD BE EXPECTED TO BE UNDERSTOOD BY CLINICIANS CARING FOR PTS AFTER LOBECTOMY". RESMED REF.#: (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444900 S8 AUTOSET TEIJIN BZD RESMED LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1