BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURVEYOR CENTRAL

    MDR report key: 5130767 · Received October 2, 2015

    Report

    Report Number
    2183461-2015-00006
    Event Type
    Death
    Date Received
    October 2, 2015
    Date of Event
    June 12, 2015
    Report Date
    October 2, 2015
    Manufacturer
    MORTARA INSTRUMENT, INC.
    Product Code
    MHX
    PMA / PMN Number
    K060135
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OUR (B)(6) IS STILL IN-PROCESS AND WE ARE FILING PAPER BECAUSE OF TECHNICAL PROBLEMS. REVIEW OF LOG FILES FROM DEVICE. SYSTEM LOG FILES WERE REVIEWED AND IDENTIFIED THIS INCIDENT IS A RESULT OF ALL ALARMS BEING MANUALLY DISABLED BY THE OPERATOR AT 12:13:15. THE CONDITION REMAINED UNTIL 04:50:45. THE SURVEYOR CENTRAL RECOGNIZED BRADYCARDIA AT 01:11:00 AND ASYSTOLE AT 01:20:00, APPROXIMATELY. DURING THIS PERIOD THE ALARMS WERE STILL DISABLED. 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

    THE CUSTOMER REPORTED THE SURVEYOR CENTRAL SYSTEM DID NOT RECOGNIZE AND DID NOT ALARM A BRADYCARDIA AND THEN AN ASYSTOLE ON A PATIENT. THE PATIENT WAS FOUND DEAD THE MORNING AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656585 SURVEYOR CENTRAL MHX MORTARA INSTRUMENT, INC. 251080242 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death