BEUDAMED
    FDA Adverse Event Death Summary report: N

    NONE

    MDR report key: 1240466 · Received November 20, 2008

    Report

    Report Number
    1218950-2008-00634
    Event Type
    Death
    Date Received
    November 20, 2008
    Date of Event
    November 5, 2008
    Report Date
    November 7, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHILLIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SENT ONCE THE INVESTIGATION IS COMPLETED. WE WILL CONSIDER THAT THE FAILURE TO RESPOND TO THE INOPS WAS A FACTOR IN THIS PT'S DEATH. THERE WAS A DELAY IN THE FACTORY BEING INFORMED OF THIS EVENT.

    Description of Event or Problem · 1

    ALTHOUGH THERE WAS NOT A PRODUCT MALFUNCTION, A DEATH OCCURRED AFTER PT WENT INTO CARDIO-PULMONARY ARREST AND THE LEADS OFF AND REPLACE BATTERY MESSAGES WERE NOT ACKNOWLEDGED IN A TIMELY MANNER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE DRT PHILIPS MEDICAL SYSTEMS 865094 (M3155)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death