BEUDAMED
    FDA Adverse Event Death Summary report: N

    S9 VPAP ST - AMERICAS

    MDR report key: 4262562 · Received November 4, 2014

    Report

    Report Number
    3007573469-2014-00021
    Event Type
    Death
    Date Received
    November 4, 2014
    Date of Event
    September 18, 2014
    Report Date
    November 4, 2014
    Manufacturer
    RESMED LTD
    Product Code
    BZD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT AN ALS PATIENT USING AN S9 VPAP ST PASSED AWAY. REF MFR 3004604967-2014-00032.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707176 S9 VPAP ST - AMERICAS NONCONTINUOUS VENTILATOR (IPPB) BZD RESMED LTD 36008

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death