BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHILIPS INFORMATION CENTER

    MDR report key: 3900336 · Received June 19, 2014

    Report

    Report Number
    1218950-2014-03480
    Event Type
    Death
    Date Received
    June 19, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K011093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY DID NOT RECEIVE AN ASYSTOLE ALARM AND THERE WAS A DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360259 PHILIPS INFORMATION CENTER MHX, DRT MHX PHILIPS MEDICAL SYSTEMS M3150B

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death