BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFORMATION CENTER NETWORK DATABASE

    MDR report key: 1422309 · Received July 24, 2009

    Report

    Report Number
    1218950-2009-00859
    Event Type
    Death
    Date Received
    July 24, 2009
    Date of Event
    February 11, 2008
    Report Date
    February 22, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K01109
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THEY EXPERIENCED PROBLEMS WITH THEIR INFORMATION CENTER LOSING WAVEFORM DATA, AND WERE IN THE PROCESS OF REPAIRING THE DEVICE WHEN A PATIENT INCIDENT OCCURRED. OF NOTE, THE PATIENT WAS ONE OF TWO PATIENTS THAT WERE NOT BEING MONITORED WITH A SPARE TELEMETRY TRANSMITTER DURING THE TIME. STAFF HAD PRIORITIZED WHICH PATIENT WOULD RECEIVE SPARE MONITORING DEVICES AND HAD MADE THE DECISION THAT THIS PATIENT COULD GO WITHOUT. THE PATIENT CODED, REQUIRING MEDICAL INTERVENTION AND WAS TRANSFERRED TO THE ICU, WHERE HE/SHE EXPIRED TWO DAYS LATER. SUBSEQUENTLY, IT WAS DETERMINED THAT THERE WAS A BROKEN RJ45 DATA CABLE AT THE TELEMETRY MAINFRAME AND A LOOSE RJ45 NETWORK CABLE AT THE INFORMATION CENTER, WHICH CAUSED THE MONITORING SYMPTOMS DESCRIBED. BOTH OF THESE FAILURES WILL BE CONSIDERED AS USER CAUSED ISSUES AND NOT AS DEVICE MALFUNCTION. NO FURTHER INVESTIGATION OR ACTION ARE WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING THE PROCESS OF TROUBLESHOOTING, A FAILURE OF THE CARE UNITS TELEMETRY SYSTEM, A PATIENT WHO WAS NOT BEING MONITORED EXPERIENCED A CODE AND REQUIRED MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFORMATION CENTER NETWORK DATABASE MHX, DRT MHX PHILIPS MEDICAL SYSTEMS M3155B

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death