BEUDAMED
    FDA Adverse Event Death Summary report: N

    NONE

    MDR report key: 1902671 · Received November 12, 2010

    Report

    Report Number
    1218950-2010-02216
    Event Type
    Death
    Date Received
    November 12, 2010
    Report Date
    November 4, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ALARM LOGS SHOW THAT THE USERS ACKNOWLEDGED THE ALARMS AT THE CENTRAL STATION APPROXIMATELY 2 MINUTES AFTER IT SOUNDED. 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 A PT DEATH OCCURRED AND THAT THE STAFF WAS UNSURE IF ALARMS SOUNDED AT THE CENTRAL STATION MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE MHX PHILIPS HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death