BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHILIPS INFORMATION CENTER

    MDR report key: 1883833 · Received October 22, 2010

    Report

    Report Number
    1218950-2010-01969
    Event Type
    Death
    Date Received
    October 22, 2010
    Report Date
    October 15, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K011093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THERE WAS A FAILURE TO ALARM. A PATIENT DEATH WAS REPORTED. BASED ON INITIAL INVESTIGATION, THE CUSTOMER STATED THAT THEY DID NOT SEE THE ALARM IN THE AUTOMATIC OVERVIEW AND AFTER THE INCIDENT, THE GROUP SETTINGS OVERVIEW WAS CHANGED FROM YELLOW-RED ALARM TO ONLY RED. THE CUSTOMER DID RECEIVE ALARMS AT THE BEDSIDE AND CENTRAL STATION, HOWEVER, THE CUSTOMER WANTED TO BE INFORMED BY THE OVERVIEW FUNCTION. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT 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 THERE WAS A FAILURE TO ALARM. A PATIENT DEATH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS INFORMATION CENTER MHX, DRT MHX PHILIPS HEALTHCARE M3150B

    Patients

    Seq Age Sex Outcome Treatment
    1 Death