BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHILIPS INFORMATION CENTER

    MDR report key: 2221343 · Received August 17, 2011

    Report

    Report Number
    1218950-2011-02378
    Event Type
    Death
    Date Received
    August 17, 2011
    Date of Event
    July 16, 2011
    Report Date
    August 12, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MHX
    PMA / PMN Number
    K011093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THERE WERE NO ALARMS AT THE CENTRAL STATION TO INDICATE THAT A PT HAD EXPIRED IN HIS ROOM. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO 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 WERE NO ALARMS AT THE CENTRAL STATION TO INDICATE THAT A PT HAD EXPIRED IN HIS ROOM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death