BEUDAMED
    FDA Adverse Event Death Summary report: N

    AS/3 TM ANESTHESIA MONITOR

    MDR report key: 482259 · Received September 5, 2003

    Report

    Report Number
    9610105-2003-00008
    Event Type
    Death
    Date Received
    September 5, 2003
    Date of Event
    August 6, 2003
    Report Date
    September 5, 2003
    Manufacturer
    INSTRUMENTARIUM CORP. DATEX-OHMEDA DIVISION
    Product Code
    CCK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DATEX-OHMEDA WAS INFORMED IN AUGUST 8, 2003: THIS MONITOR WAS REPORTED AS HAVING NOT SOUNDED ITS ALARM WHEN THE PT BECAME ASYSTOLIC. APPARENTLY THE ASYSTOLE ALARM MESSAGE WAS ON THE SCREEN AND FLASHING BUT THERE WAS NO AUDIBLE ALARM. THIS INFORMATION COULD ONLY BE GIVEN BY ONE MEMBER OF STAFF AND COULD NOT BE VERIFIED DUE TO THE FACT THAT THERE WAS ONLY ONE OTHER STAFF MEMBER IN THE UNIT AT THE TIME, WITH ANOTHER PT. THIS INCIDENT OCCURRED EARLY IN THE MORNING. PLEASE NOTE THAT EVEN THOUGH THERE WAS A PT FATALITY RESULTING FROM THIS INCIDENT, IT IS NOT THE CONTENTION OF THE HOSPITAL THAT THE PART PLAYED BY THE MONITOR WAS A CONTRIBUTING FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AS/3 TM ANESTHESIA MONITOR DATEX-OHMEDA 8-MODULE FRAME CCK INSTRUMENTARIUM CORP. DATEX-OHMEDA DIVISION F-CU8-22-03 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death
    2