BEUDAMED
    FDA Adverse Event Death Summary report: N

    NONE

    MDR report key: 1912843 · Received November 23, 2010

    Report

    Report Number
    1218950-2010-02372
    Event Type
    Death
    Date Received
    November 23, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE SHUT DOWN UNEXPECTEDLY DURING A CARDIAC ARREST. THE INVOLVED PT DIED. WE HAVE REQUESTED ADDITIONAL INFORMATION AND AT THIS TIME, IT IS NOT KNOWN WHAT ROLE THE DEVICE PLAYED IN THE PT OUTCOME. THIS COMPLAINT REMAINS UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION ABOUT THIS EVENT.

    Description of Event or Problem · 1

    THIS CUSTOMER REPORTED THAT THE DEVICE SHUT DOWN UNEXPECTEDLY DURING A CARDIAC ARREST. THE INVOLVED PT DIED. WE HAVE REQUESTED ADDITIONAL INFORMATION, AND AT THIS TIME, IT IS NOT KNOWN WHAT ROLE THE DEVICE PLAYED IN THE PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE MHX PHILIPS HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death