BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE INFORMATION CENTER CLIENT

    MDR report key: 1921301 · Received December 6, 2010

    Report

    Report Number
    1218950-2010-02424
    Event Type
    Death
    Date Received
    December 6, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K081983
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT A PATIENT EXPERIENCED A LONG PERIOD OF BRADYCARDIA BUT THE RED ALARM WAS NOT STORED. BASED ON AVAILABLE INFO, THE HOSP'S RISK MANAGER (RM) WAS UNAWARE OF THE ISSUE AND CONFIRMED THAT THE DEVICE DID PRODUCE ALARMS. THE AVAILABLE INFO SUPPORTS THAT THERE IS NO RELATIONSHIP BETWEEN MONITORING AND THIS PT'S DEATH. THIS EVENT IS BEING REPORTED ONLY BECAUSE A PATIENT DIED WHILE BEING MONITORED BY A PHILIPS MONITOR. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO REGARDING THIS INCIDENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT EXPERIENCED A LONG PERIOD OF BRADYCARDIA BUT THE RED ALARM WAS NOT STORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIVUE INFORMATION CENTER CLIENT MHX PHILIPS HEALTHCARE 865094 (M3155)

    Patients

    Seq Age Sex Outcome Treatment
    1