BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M300

    MDR report key: 6028188 · Received October 13, 2016

    Report

    Report Number
    1220063-2016-00035
    Event Type
    Injury
    Date Received
    October 13, 2016
    Date of Event
    September 26, 2016
    Report Date
    December 2, 2016
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K151860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS STARTED BUT HAS NOT YET BEEN CONCLUDED. THE INVESTIGATION RESULT WILL BE REPORTED IN THE FOLLOW UP REPORT.

    Additional Manufacturer Narrative · 1

    THE M300 ALARM AND ERROR LOGS WERE REVIEWED AND DID NOT CONTAIN ENTRIES FOR THE REPORTED ISSUE WHICH OCCURRED ON (B)(6) 2016 BETWEEN 8AM-8:45AM. THE ICS (INFINITY CENTRAL STATION) LOGS WERE REVIEWED AND INDICATED BED LABEL T-04 WAS RUNNING MULTIPLE CRITICAL LOW BATTERY ALARMS AND MESSAGES BETWEEN (B)(6) 2016 07:47:07 TO (B)(6) 2016 08:12:08. ON (B)(6) 2016 08:11:23, THE ICS LOGS SHOWED THAT THE M300 WAS NOT BEING MONITORED AT THE ICS WHICH MEANT THE M300 SHUTDOWN DUE TO A DEPLETED BATTERY. WHERE THE M300 SHUTDOWN FOR A DEPLETED BATTERY, THE LOGS WERE NOT STORED FOR THE PATIENT EVENT AS PATIENT MONITORING WAS NOT POSSIBLE. THE M300 SHUTDOWN DUE TO A DEPLETED BATTERY, WHICH THE ICS ALARMED FOR ON MULTIPLE OCCASIONS PRIOR TO THE PATIENT EVENT. THERE WAS NO MALFUNCTION AND THE DEVICE DID NOT CONTRIBUTE TO THE ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2016 BETWEEN 8:00AM AND 8:45AM THE PATIENT ON M300-MONITORING SPOT 4 IN ROOM (B)(6) IN THE WARD B4 TELEMETRIE COLLAPSED WITH VENTRICULAR FIBRILLATION. THE M300 REPORTEDLY DID NOT ALARM. THE PATIENT IN THE NEIGHBORING BED REACTED IMMEDIATELY AND ACTIVATED THE ALARM CALL. THE REANIMATION TEAM RESUSCITATED THE PATIENT AND RELOCATED HIM TO THE ICU FOR OBSERVATION/TREATMENT. THERE WAS NO INFORMATION REGARDING THE FURTHER STATE OF THE PATIENT.

    Description of Event or Problem · 1

    PLEASE REFER TO THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680270 M300 PHYSIOLOGICAL MONITORING SYSTEM CBK DRAEGER MEDICAL SYSTEMS, INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1