BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE INFORMATION CENTER

    MDR report key: 1841160 · Received September 15, 2010

    Report

    Report Number
    1218950-2010-01582
    Event Type
    Death
    Date Received
    September 15, 2010
    Report Date
    September 9, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K081983
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT A RED ALARM DID NOT SOUND AT THE INFO CENTER OR AT THE BEDSIDE. BASED ON THE AVAILABLE INFO, A NURSE AND DOCTOR WERE IN FRONT OF THE CENTRAL STATION AND SAW A VISUAL RED DESAT ALARM AT 60% WITH NO SOUND AT THE SDN BEDSIDE. THE CUSTOMER INFORMED PHILIPS THAT THERE WAS NO ALARM AT THE INFO CENTER AND BEDSIDE. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL 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 RED ALARM DID NOT SOUND AT THE INFO CENTER OR AT THE BEDSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIVUE INFORMATION CENTER MHX PHILIPS HEALTHCARE 862067 (M3150B)

    Patients

    Seq Age Sex Outcome Treatment
    1