BEUDAMED
    FDA Adverse Event Death Summary report: N

    F-CU8

    MDR report key: 1051287 · Received May 21, 2008

    Report

    Report Number
    9610105-2008-00015
    Event Type
    Death
    Date Received
    May 21, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 21, 2008
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE ALLEGEDLY NO ALARMS DISPLAYED AT THE CENTRAL STATION. THE PHYSICIAN REPORTED THAT A LEAD CABLE HAD FALLEN OFF THE PT. A PT DEATH WAS REPORTED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 F-CU8 PATIENT MODULAR MONITOR MHX GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death