BEUDAMED
    FDA Adverse Event Death Summary report: N

    S/5 MONITOR

    MDR report key: 836544 · Received April 10, 2007

    Report

    Report Number
    9610105-2007-00007
    Event Type
    Death
    Date Received
    April 10, 2007
    Date of Event
    February 24, 2007
    Report Date
    April 10, 2007
    Manufacturer
    GE HEALTHCARE FINLAND OY
    Product Code
    BSZ
    PMA / PMN Number
    k051400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PATIENT DEATH WAS REPORTED AND UNIT REPORTEDLY DID NOT ALARM. THE CUSTOMER HAS REFUSED TO PROVIDE THE DEVICE FOR EVALUATION. THE CUSTOMER IS REPORTEDLY HAVING THE DEVICE EVALUATED BY AN INDEPENDENT EXPERT IN AGREEMENT WITH ANOTHER COUNTRY. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS TILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S/5 MONITOR ANESTHESIA MONITOR BSZ GE HEALTHCARE FINLAND OY F-CUB *

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death