BEUDAMED
    FDA Adverse Event Death Summary report: N

    M1176A COMPONENT MONITORING SYSTEM

    MDR report key: 431732 · Received December 10, 2002

    Report

    Report Number
    9610816-2002-00189
    Event Type
    Death
    Date Received
    December 10, 2002
    Date of Event
    December 11, 2000
    Report Date
    October 9, 2002
    Manufacturer
    AGILENT TECHNOLOGIES DEUTSCHLAND GMBH
    Product Code
    DRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS MEDICAL SYSTEMS THAT THE ANESTHESIA MACHINE, WHICH PROVIDED OXYGEN TO THE PT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WAS SHUT OFF IN ORDER TO TAKE A CHOLANGIOGRAM. IT IS ALLEGED THAT THE ALARM SYSTEM ON THE PT MONITOR WAS PROGRAMMED IN THE "ALARMS SUSPENDED" MODE, WHICH TURNED OFF ALL AUDIBLE MONITOR ALARMS DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M1176A COMPONENT MONITORING SYSTEM BEDSIDE MONITOR DRT AGILENT TECHNOLOGIES DEUTSCHLAND GMBH M1094B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death