BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHILIPS INFORMATION CENTER

    MDR report key: 1712814 · Received June 3, 2010

    Report

    Report Number
    1218950-2010-00829
    Event Type
    Death
    Date Received
    June 3, 2010
    Date of Event
    May 21, 2010
    Report Date
    May 21, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K01109
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT A PT CODE EVENT OCCURRED AND THEY WERE UNABLE TO OBTAIN RETROSPECTIVE DATA AFTER THE CODE. THE CUSTOMER ALSO STATED ON (B) (6) 2010, THAT TO HER KNOWLEDGE, THE REBOOTING OF THE DATABASE SERVER (DBS) AND NETWORKED INFO CENTER DID NOT CAUSE/CONTRIBUTE TO THE ISSUE BUT IMPACTED THEIR ABILITY TO OBTAIN RETROSPECTIVE DATA AFTER THE CODE. ON (B) (6) 2010, THE CUSTOMER INDICATED THAT THE PT LATER EXPIRED. THE DBS REBOOTED CAUSING MONITORING. IF TELEMETRY WERE IN USE, THE M3150A/B DEVICE MONITORING THE PT WOULD TEMPORARILY STOP MONITORING AND WOULD AUTOMATICALLY BE RECONFIGURED TO BE IN LOCAL DATABASE MODE WITH THE RESTORATION OF MONITORING WITHIN 5 MINUTES. CONNECTED INFO CENTERS PROVIDE VISUAL INDICATORS WHEN THEY LOSE CONNECTIVITY WITH THE DBS. THE ISSUE WOULD BE OBVIOUS TO USERS OBSERVING THE INFO CENTER DISPLAY AND ALTERNATE MEANS OF MONITORING WOULD BE IMPLEMENTED AS WARRANTED DURING THE TIMEFRAME THE DEVICE IS REBOOTING INTO LOCAL MODE. 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. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PT CODE EVENT OCCURRED AND THAT THEY WERE UNABLE TO OBTAIN RETROSPECTIVE DATA.

    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