BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFORMATION CENTER NETWORK DATABASE

    MDR report key: 1660418 · Received April 13, 2010

    Report

    Report Number
    1218950-2010-00501
    Event Type
    Death
    Date Received
    April 13, 2010
    Report Date
    February 10, 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 A PT INCIDENT OCCURRED SEVERAL MONTHS PRIOR 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 DNR/DN, WITH A DIAGNOSIS OF ANEMIA, MALNUTRITION AND FAILURE TO THRIVE WHO WAS BEING MONITORED ON TELEMETRY. SHE WAS UNSURE OF WHAT RHYTHM ALARM THEY WERE EXPECTING. THE ICU CONTACTED THE MED/SURG UNIT TO INFORM THEM TO CHECK ON THE PT BECAUSE THERE WASN'T ANY PULSE OXIMETRY OR HEART RATE SHOWING ON THE TELEMETRY. NO EMERGENT CARE WOULD HAVE BEEN PROVIDED TO THIS PT BASED ON THEIR CODE STATUS. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO REGARDING THIS INCIDENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WIL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PT INCIDENT OCCURRED SEVERAL MONTHS PRIOR 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