BEUDAMED
    FDA Adverse Event Other Summary report: N

    DATEX-OHMEDA S/5 LIGHT MONITOR

    MDR report key: 515002 · Received January 21, 2004

    Report

    Report Number
    9610105-2004-00003
    Event Type
    Other
    Date Received
    January 21, 2004
    Date of Event
    November 27, 2003
    Report Date
    January 19, 2004
    Manufacturer
    INSTRUMENTARIUM CORP./DATEX-OHMEDA DIVISION
    Product Code
    DPS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THERE WAS NO ALARM ACTIVATION BY THE MONITOR, WHEN THE PATIENT WAS IN HYPOTENSION (BELLOW THE LOW ALARM SETTING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATEX-OHMEDA S/5 LIGHT MONITOR DATEX-OHMEDA S/5 MULTIPARAMETER PATIENT MONITOR DPS INSTRUMENTARIUM CORP./DATEX-OHMEDA DIVISION F-LM1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other