BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE INFORMATION CENTER

    MDR report key: 3092218 · Received April 30, 2013

    Report

    Report Number
    1218950-2013-01523
    Event Type
    Death
    Date Received
    April 30, 2013
    Date of Event
    March 31, 2013
    Report Date
    April 2, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K062271
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFO CONCERNING THE IS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY DID NOT GET ALARMS WHEN THE PATIENT'S HEART RATE WAS IN THE "TEENS." THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186590 INTELLIVUE INFORMATION CENTER MHX PHILIPS MEDICAL SYSTEMS M3150

    Patients

    Seq Age Sex Outcome Treatment
    1 Death