BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHILIPS INFORMATION CENTER

    MDR report key: 1679164 · Received May 7, 2010

    Report

    Report Number
    1218950-2010-00660
    Event Type
    Death
    Date Received
    May 7, 2010
    Date of Event
    March 2, 2010
    Report Date
    April 28, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K01109
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED A PT CODE OCCURRED AND THE PT SUBSEQUENTLY EXPIRED. THE CUSTOMER CONTACTED PHILIPS REQUESTING AN ANALYSIS OF LOG DATA. IT WAS LATER DETERMINED THAT A FEMALE PT ON TELEMETRY HAD LEFT THE FLOOR 3 HOURS FOR TESTS AND THE PT'S ECG SIGNAL WAS LOST AT 10:30 AM AND NEVER RETURNED, THOUGH SHE WAS IN AND OUT OF 3 DIFFERENT TESTING AREAS, SOME OF WHICH WERE STATED TO HAVE BEEN EXPECTED TO HAVE ADEQUATE ANTENNA COVERAGE TO BE ABLE TO PROVIDE A SIGNAL. THE CUSTOMER IS UNSURE WHAT INOP'S MAY HAVE BEEN PROVIDED OR IF THE BATTERY WAS WEAK OR IF THE LEADS WERE OFF BUT WANTED HELP TO DETERMINE THIS. THE PT CODED WHEN OFF THE FLOOR, EMERGENCY RESPONSE TEAM WAS CALLED, BUT THE PT EXPIRED. A PHILIPS FIELD SERVICE ENGINEER (FSE) WENT ONSITE AND GATHERED LOGS, BUT THE INCIDENT OCCURRED ON MARCH 2ND AND THE LOG DATA HAD ALREADY "ROLLED" DUE TO THE PASSAGE OF TIME. THEREFORE, NO FURTHER INFO COULD BE PROVIDED REGARDING ANY ALARMS PROVIDED DURING THE TIME THE PT WAS OFF THE FLOOR. THE AVAILABLE INFO DOES NOT SUPPORT THAT THERE WAS ANY MALFUNCTION OR THAT THERE WAS A USER ERROR. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PT DEATH HAD OCCURRED, AND WAS REQUESTING ASSISTANCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death