BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURVEYOR CENTRAL

    MDR report key: 5130768 · Received October 2, 2015

    Report

    Report Number
    2183461-2015-00003
    Event Type
    Death
    Date Received
    October 2, 2015
    Date of Event
    March 31, 2014
    Report Date
    October 2, 2015
    Manufacturer
    MORTARA INSTRUMENT, INC.
    Product Code
    MHX
    PMA / PMN Number
    K060135
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OUR WEBTRADER ACCOUNT IS STILL IN-PROCESS AND WE ARE FILING PAPER BECAUSE OF TECHNICAL PROBLEMS. REVIEW OF LOG FILES FROM DEVICE. SYSTEM LOG FILES WERE REVIEWED. BY DESIGN HIGH PRIORITY ALARMS PERSIST UNTIL ACKNOWLEDGED BY THE OPERATOR. IN THIS EVENT THE VFIB ALARM STARTED AT 06:15:38 AND WAS NOT ACKNOWLEDGED (SILENCED) UNTIL 06:46:12. AS SOON AS THE VFIB ALARM WAS ACKNOWLEDGED AT 06:46:12, THE CARDIAC ARREST ALARM WAS IMMEDIATELY ISSUED. THE INVESTIGATION INDICATES THAT THE SYSTEM WAS OPERATING NORMALLY AND WITHIN PERFORMANCE SPECIFICATIONS. THE INFORMATION REVIEWED DID NOT INDICATE THERE WAS ANY SYSTEM MALFUNCTION THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DURING SHIFT CHANGEOVER STARTING AT 06:00, WHILE NURSES WERE OUTSIDE THE ROOM AND NOT MONITORING THE CENTRAL MONITOR, A PATIENT MONITOR ALARMED. THE ALARMS WERE ONLY RECOGNIZED BY THE ALARM TONE. THE STORED ALARMS WERE AS FOLLOWS: 05:56:05 BRADYCARDIA ALARM; 06:15:35 TACHYCARDIA ALARM; 06:15:38 VFIB ALARM DISPLAYED UNTIL THE ARREST ALARM); 06:46:12 ARREST ALARM. THE FACILITY IS QUESTIONING WHY THE ARREST ALARM DISPLAYED AND STORED AT 06:46:12 AND NOT AT THE TIME THE FIB WENT INTO THE FIRST ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656912 SURVEYOR CENTRAL MHX MORTARA INSTRUMENT, INC. SCSYS-ADD-GBCCX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Death