BEUDAMED
    FDA Adverse Event Death Summary report: N

    OBSOLETE S9 VPAP ST - AMERICAS

    MDR report key: 7068891 · Received November 29, 2017

    Report

    Report Number
    3004604967-2017-01695
    Event Type
    Death
    Date Received
    November 29, 2017
    Report Date
    November 29, 2017
    Manufacturer
    RESMED LTD
    Product Code
    BZD
    PMA / PMN Number
    K102513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED FOR AN ENGINEERING INVESTIGATION AND REQUESTED ADDITIONAL INFORMATION SURROUNDING THE NATURE OF THE EVENT. AT THIS TIME THERE IS NO INFORMATION THAT SUGGESTS THE DEVICE CONTRIBUTED TO THE DEATH. IF ADDITIONAL INFORMATION IS MADE AVAILABLE OR THE DEVICE IS RETURNED FOR AN INVESTIGATION THEN RESMED WILL SUBMIT A FOLLOW-UP REPORT WITH THE APPROPRIATE NARRATIVE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT A PATIENT ON AN S9 VPAP ST DEVICE EXPIRED. THE PATIENT WAS REPORTED TO HAVE STOPPED BREATHING WHILE ON BI-PAP THERAPY. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION OR THAT THE DEVICE CONTRIBUTED TO THE PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845353 OBSOLETE S9 VPAP ST - AMERICAS BZD RESMED LTD 36008

    Patients

    Seq Age Sex Outcome Treatment
    1 Death