BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFINITY CENTRAL STATION

    MDR report key: 7126002 · Received December 18, 2017

    Report

    Report Number
    1220063-2017-00065
    Event Type
    Death
    Date Received
    December 18, 2017
    Date of Event
    December 12, 2017
    Report Date
    December 18, 2017
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K061379
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SENT AT THE CONCLUSION OF THIS INVESTIGATION.

    Additional Manufacturer Narrative · 1

    UPDATE 19DEC2017: THE CUSTOMER HAS CLARIFIED THAT THERE WAS NO FAILURE OF A DRAEGER DEVICE (NO FAILURE TO ALARM)/NO ALLEGATION OF A DRAEGER DEVICE IMPACTING THE PATIENT OUTCOME - THIS WAS REPORTED IN ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OFF-LINE ALARM ISSUES WHERE THE INVOLVED PATIENT DIED. MULTIPLE OFFLINE ALARMS WERE REPORTED FROM 16:30-23:30, AT 23:30 THE RECORDING STOPPED IN THE LONG-TERM TREND AND THERE WAS NO ALARM. SUBSEQUENT DATA ANALYSIS OF THE IMPLANTED PACEMAKER REVEALED THAT THE DEFIBRILLATOR FUNCTION IN THE PACEMAKER HAD STARTED AT 00:13 (TIME SHIFT IN THE PACEMAKER BECAUSE OF SUMMER / WINTER TIME). THE PATIENT WAS FOUND DEAD IN BED AT 00:30. A RESUSCITATION WAS UNSUCCESSFUL. DURING THE FUNCTION CHECK, THE M300 TRANSMITTER TELE-9 AND THE ICS WORKED WITHOUT ANY PROBLEMS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OFF-LINE ALARM ISSUES WHERE THE INVOLVED PATIENT DIED. MULTIPLE OFFLINE ALARMS WERE REPORTED FROM 16:30-23:30, AT 23:30 THE RECORDING STOPPED IN THE LONG-TERM TREND AND THERE WAS NO ALARM. SUBSEQUENT DATA ANALYSIS OF THE IMPLANTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906093 INFINITY CENTRAL STATION PHYSIOLOGICAL MONITORING SYSTEM CBK DRAEGER MEDICAL SYSTEMS, INC MS18500

    Patients

    Seq Age Sex Outcome Treatment
    1 Death