BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHILIPS INFORMATION CENTER

    MDR report key: 1637362 · Received March 18, 2010

    Report

    Report Number
    1218950-2010-00352
    Event Type
    Death
    Date Received
    March 18, 2010
    Date of Event
    March 16, 2010
    Report Date
    March 16, 2010
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    MHX
    PMA / PMN Number
    K011093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE NURSES DID NOT HEAR AN ALARM DURING A PATIENT INCIDENT. BASED ON THE AVAILABLE INFORMATION AND PATIENT LOGS, IT SHOWS THAT THE PATIENT PULLED OFF THEIR LEADSET AND THE MONITOR FLATLINED ON THE WAVE REVIEW. PHILIPS IS UNABLE TO DETERMINE IF THIS IS A USER ERROR OR IF THE LACK OF STAFF AWARENESS WAS A FACTOR IN THE DEATH OF THE PATIENT. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION 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 THE NURSES DID NOT HEAR AN ALARM DURING A PATIENT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS INFORMATION CENTER MHX, DRT MHX AGILENT TECHNOLOGIES, INC. M3150B

    Patients

    Seq Age Sex Outcome Treatment
    1 Death