BEUDAMED
    FDA Adverse Event Death Summary report: N

    VPAP IV ST EUR2

    MDR report key: 2441796 · Received February 3, 2012

    Report

    Report Number
    3004604967-2012-00007
    Event Type
    Death
    Date Received
    February 3, 2012
    Date of Event
    January 1, 2012
    Report Date
    February 3, 2011
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K080131
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRELIMINARY INVESTIGATION WAS CONDUCTED AT RESMED (B)(4). THE DEVICE WAS FUNCTIONALLY TESTED AND PERFORMED TO SPECIFICATION. NO ERROR MESSAGES WERE OBSERVED OR REPRODUCED WHEN TESTED. THE DEVICE WAS SENT TO THE DESIGN HOUSE IN (B)(4) FOR AN ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED (B)(4) THAT A PATIENT BEING TREATED WITH A VPAP IV ST DEVICE PASSED AWAY. DURING THE TREATMENT, THE ON CALL STAFF ALLEGED AN ERROR MESSAGE APPEARED ON THE SCREEN. THE PATIENT WAS TRANSFERRED TO ICU AND PASSED AWAY SEVERAL HOURS LATER. IT WAS REPORTED THE PATIENT WAS NOT USING THE DEVICE WHEN THEY PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VPAP IV ST EUR2 BZD RESMED LTD. 26115

    Patients

    Seq Age Sex Outcome Treatment
    1 Death