BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D-O S/5 CRITICAL CARE SW LICENSE W/EXTENDED ARRHYTHMIA

    MDR report key: 448991 · Received March 19, 2003

    Report

    Report Number
    9610105-2003-00004
    Event Type
    Injury
    Date Received
    March 19, 2003
    Date of Event
    February 13, 2003
    Report Date
    March 19, 2003
    Manufacturer
    INSTRUMENTARIUM CORP.
    Product Code
    DSI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS PACED AT A RATE OF APPROXIMATELY 100 BEATS PER MINUTE, THE PATIENT SUFFERED A VENTRICULAR FIBRILLATION (VF), BUT THE MONITOR FAILED TO RECOGNIZE THIS EVENT UNTIL APPROX 1 MIN AFTER THE EVENT TOOK PLACE. ALL ALARMS WERE ACTIVE BUT DESPITE THIS, NO VF ALARM WAS DISPLAYED. THE PATIENT WAS SUCCESSFULLY RESUSCITATED. ADDITIONAL INFORMATION WAS RECEIVED IN FEBRUARY 26, 2003: LOW POTASSIUM FOLLOWING CARDIAC SURGERY WAS THE CLINICAL REASON FOR ARRHYTHMIAS. THE PATIENT HAD VENTRICULAR PACEMAKER WITH TEMPORARY EXTERNAL EPICARDIAL LEADS. VENTRICULAR FIBRILLATION OCCURRED 14.54. THE CLINICAN COULD GET THE MONITOR TO RECOGNIZE THAT THE PATIENT WAS HAVING A V-F ARREST BY SWITCHING OF THE PACING BOX. ONCE THIS WAS SWITCHED OFF, THEN THE MONITOR ALARMED TO VF, PRIOR TO THIS THE ONLY ALARM THAT TRIGGERED WAS THAT OF THE LOW ARTERIAL PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D-O S/5 CRITICAL CARE SW LICENSE W/EXTENDED ARRHYTHMIA DATEX-OHMEDA MULTIPARAMETER PATIENT MONITOR DSI INSTRUMENTARIUM CORP. L-ICU02A *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R