BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATEX-OHMEDA S/5 CRITICAL CARE UPGRADE SOFTWARE LICENSE,U-0

    MDR report key: 448623 · Received March 12, 2003

    Report

    Report Number
    9610105-2003-00003
    Event Type
    Malfunction
    Date Received
    March 12, 2003
    Date of Event
    February 13, 2003
    Report Date
    March 12, 2003
    Manufacturer
    DATEX-OHMEDA DIVISION, INSTRUMENTARIUM CORP.
    Product Code
    DSI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DATEX-OHMEDA MONITOR DID NOT ACTIVATE THE SPO2 AND INVASIVE PRESSURE ALARMS. THIS LED TO A REANIMATION OF THE PATIENT. MRSA-PATIENT WAS ISOLATED IN A SPECIFIC ISOLATION-BOX. THE PATIENT WAS INTUBATED AND CONNECTED TO VENTILATOR. THE PATIENT HAD A ASYSTOLE BUT TEN MINUTES BEFORE THIS, THE SPO2-SENSOR FAILED WITHOUT AN ACOUSTIC ALARM. THE USERS NOTICED THE SITUATION FROM MONITOR'S HEART RATE AND INVASIVE BLOOD PRESSURE ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATEX-OHMEDA S/5 CRITICAL CARE UPGRADE SOFTWARE LICENSE,U-0 DATEX-OHMEDA MULTIPARAMETER PATIENT MONITOR DSI DATEX-OHMEDA DIVISION, INSTRUMENTARIUM CORP. U-00C01 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening| O MONITOR FRAME F-CU8