BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFORMATION CENTER NETWORK DATABASE

    MDR report key: 1660417 · Received April 13, 2010

    Report

    Report Number
    1218950-2010-00500
    Event Type
    Death
    Date Received
    April 13, 2010
    Date of Event
    July 31, 2009
    Report Date
    April 9, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K01109
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT SEVERAL MONTHS PRIOR, A PT INCIDENT OCCURRED AND THERE WAS A SUBSEQUENT SOFTWARE UPGRADE. BASED ON ADDITIONAL INFO OBTAINED FROM THE HOSPITAL'S RISK MGR ON 04/09/10, THERE WAS A DEATH ASSOCIATED WITH THIS COMPLAINT. THE PT WAS A FULL CODE WITH THE DIAGNOSES OF DEHYDRATION, HYPONATREMIA, EXCORIATION OF BUTTOCKS, WEAKNESS, ATAXIC GAIT, PERIPHERAL NEUROPATHY, ELEVATED LFTS, WHO WAS POST-CARDIAC CATHETERIZATION ON (B) (6) 2009, AND PLACED ON TELEMETRY MONITORING. ON (B) (6) 09 AT 1810, HE WAS FOUND UNRESPONSIVE WITHOUT PULSE OR HEART BEATING. BASED ON THE INFO, PHILIPS IS UNSURE WHAT RHYTHM THEY WOULD BE EXPECTING OR THE SETTINGS AT THE TIME THE PT WAS IN. THE NURSE THAT WAS CARING FOR PT A CLAIMS THAT THIS PT WAS CONSTANTLY TAKING OFF LEADS THROUGHOUT THE DAY. PER THE NURSE, IT IS HARD TO TELL IF HE WAS ON THE TELEMETRY DEVICE AND THAT THE PT'S LEADS WERE OFF WHEN THE PT WAS FOUND DOWN. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL 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 SEVERAL MONTHS PRIOR, A PT INCIDENT OCCURRED AND THERE WAS A SUBSEQUENT SOFTWARE UPGRADE.

    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 Death