BEUDAMED
    FDA Adverse Event Death Summary report: N

    PATIENT WORN DEVICE

    MDR report key: 1267743 · Received December 16, 2008

    Report

    Report Number
    1218950-2008-00727
    Event Type
    Death
    Date Received
    December 16, 2008
    Date of Event
    December 14, 2008
    Report Date
    December 14, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K9935160
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHILIP IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SENT ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TRANSMITTER DID NOT TRANSMIT A VITAL FOR A 1HR LAPSE TIME PERIOD, WHICH RESULTED IN A PATIENT CODING AND THE NURSING STAFF WERE NOT AWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATIENT WORN DEVICE DSI PHILIPS MEDICAL SYSTEMS M4841A

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death