BEUDAMED
    FDA Adverse Event Death Summary report: N

    CMS MAIN FRAME

    MDR report key: 1304483 · Received February 3, 2009

    Report

    Report Number
    9610816-2009-00008
    Event Type
    Death
    Date Received
    February 3, 2009
    Date of Event
    January 16, 2009
    Report Date
    January 19, 2009
    Manufacturer
    AGILENT TECHNOLOGIES DEUTSCHLAND
    Product Code
    DRT
    PMA / PMN Number
    K002758
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALARM REVIEW DATA WAS CONSIDERED, AND SHOWS A LEADS-OFF STATE PERSISTING FOR OVER 10 MINUTES BEFORE THE PATIENT'S CONDITION WAS DIAGNOSED. PHILIPS IS CONSIDERING THAT THE DELAY IN TREATMENT WAS A FACTOR IN THE ADVERSE OUTCOME. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT, AND THIS COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SENT ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MONITOR DID NOT WARN (ALARM) FOR A CARDIAC ARREST. WHEN THE STAFF ENTERED THE PATIENT'S ROOM, THE BEDSIDE MONITOR HAD A FLAT TRACE AND NO ALARM SIGNALED FOR THIS PROBLEM. THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CMS MAIN FRAME DRT AGILENT TECHNOLOGIES DEUTSCHLAND M1046A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death