BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHILIPS INFORMATION CENTER

    MDR report key: 1736084 · Received June 22, 2010

    Report

    Report Number
    1218950-2010-00984
    Event Type
    Death
    Date Received
    June 22, 2010
    Date of Event
    June 17, 2010
    Report Date
    June 17, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K011093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT PER NURSING STAFF, NO ALARMS WERE PROVIDED AT ANY MONITOR OR VIA THE EMERGIN PAGING SYSTEM AS THE PATIENT'S CONDITION DETERIORATED. THERE WAS NO DEVICE MALFUNCTION. THE HOSPITAL'S BIOMEDICAL ENGINEER TESTED ALL INVOLVED DEVICES POST INCIDENT AND VERIFIED THAT YELLOW AND RED ALARMS WERE BEING PROVIDED AS APPROPRIATE FOR SIMULATED EVENTS, AND THAT ALARMS WERE BEING PROVIDED VIA THE PAGING SYSTEM. A PHILIPS FIELD SERVICE ENGINEER (FSE) TESTED THE DEVICE POST INCIDENT AND VERIFIED THAT YELLOW AND RED ALARMS WERE BEING PROVIDED AS APPROPRIATE FOR SIMULATED EVENTS, AND THAT ALARMS WERE BEING PROVIDED VIA THE PAGING SYSTEM. CENTRAL STATION AND PAGING SYSTEM LOG FILES SHOW THAT ALARMS WERE BEING PROVIDED DURING THE REPORTED INCIDENT TIMEFRAME AND WERE ACKNOWLEDGED AT THE CENTRAL STATION. 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 BIOMEDICAL ENGINEER REPORTED THAT PER NURSING STAFF, NO ALARMS WERE PROVIDED AT ANY MONITOR OR VIA THE EMERGIN PAGING SYSTEM AS THE PT'S CONDITION DETERIORATED.

    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