BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHILIPS INFORMATION CENTER

    MDR report key: 2041270 · Received March 29, 2011

    Report

    Report Number
    1218950-2011-00798
    Event Type
    Death
    Date Received
    March 29, 2011
    Report Date
    March 24, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K011093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE INOP REPORTED OCCURS AFTER OTHER INOP CONDITIONS HAVE NOT BEEN RESOLVED OR AFTER BATTERIES ARE REMOVED FROM THE TELEMETRY TRANSMITTER. THESE INOPS ARE OBVIOUS AND WE WILL CONSIDER THAT THE FAILURE TO RESOLVE THEM MAY HAVE BEEN A FACTOR IN THIS PT'S DEATH. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L 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 RECEIVING A "TRANSMITTER OFF" INDICATOR YET FOUND THE PT IN CARDIOPULMONARY ARREST, RESULTING IN THE PT DEATH. THE CUSTOMER HAS ALLEGED HAVING INTERMITTENT OPERATIONAL ISSUES WITH THEIR TELEMETRY SYSTEM THAT THEY WANT TO BE EVALUATED.

    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