BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOL

    MDR report key: 2250781 · Received September 14, 2011

    Report

    Report Number
    9611500-2011-00028
    Event Type
    Death
    Date Received
    September 14, 2011
    Date of Event
    August 14, 2011
    Report Date
    August 24, 2011
    Manufacturer
    DRAGER MEDICAL GMBH
    Product Code
    MHX
    PMA / PMN Number
    K092788
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING, THE RESULTS WILL BE REPORTED IN A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "DUE TO THE DELAY BETWEEN OF THE ECG AND BLOOD PRESSURE CURVE ON THE CENTRAL STATION, A DANGEROUS CARDIAC ARRHYTHMIA WAS MISINTERPRETED AS AN ARTEFACT. A FURTHER CARDIAC ARRHYTHMIA WHICH OCCURRED 24 MINUTES LATER RESULTED IN THE DEATH OF THE PATIENT. IF MEDICAL PERSONNEL HAD BEEN ABLE TO RESPOND TO THE FIRST ARRHYTHMIA, IT IS POSSIBLE THAT THE SECOND, FATAL ARRHYTHMIA COULD HAVE BEEN TREATED SUCCESSFULLY. THE PATIENT, HOWEVER, WAS SUFFERING FROM A GENERALLY SEVERE MEDICAL CONDITION AND HAD A HIGH MORTALITY RISK REGARDLESS OF THE MALFUNCTION OF THE CENTRAL STATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOL MONITOR, PHYSIOLOGICAL, PATIENT MHX DRAGER MEDICAL GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death