BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURVEYOR CENTRAL

    MDR report key: 5130850 · Received October 2, 2015

    Report

    Report Number
    2183461-2015-00005
    Event Type
    Injury
    Date Received
    October 2, 2015
    Date of Event
    February 20, 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 WEBTRADER ACCOUNT IS STILL IN-PROGRESS AND WE ARE FILING PAPER BECAUSE OF TECHNICAL PROBLEMS. REVIEW OF LOG FILES FROM DEVICE. SYSTEM LOG FILES WERE REVIEWED AND IDENTIFIED THIS INCIDENT INVOLVED A PATIENT W/A PACEMAKER AND IMPLANTABLE DEFIBRILLATOR. THE DETECTION LEADS WERE SET TO V1 AND V5 AND DISPLAYED LOW VOLTAGE. THE PATIENT'S ECG PATTERN DID NOT TRIGGER ANY CONDITIONS WHICH RESULT IN A HIGH PRIORITY ALARM. THE SINUSOIDAL SHAPE OF THE ECG IN THE DETECTION CHANNELS WERE NOT SIMILAR ENOUGH TO QRS COMPLEXES TO TRIGGER A DETECTION FOR EACH PERIOD, ALTHOUGH, WHEN AMPLITUDE WAS HIGHER OR THE WAVEFORM BECAME SLIGHTLY MORE PRONOUNCED, SEVERAL BEAT DETECTIONS WERE TRIGGERED. FOR THIS PATIENT, DETECTION LEADS V1 AND V5 WERE NOT IDEAL FOR RELIABLE QRS DETECTION. THE AMPLITUDE OF V1 WAS LOW AND THAT LEAD SHOULD HAVE BEEN AVOIDED. A DIFFERENT CHOICE OF DETECTION LEADS COULD HAVE LED TO A DIFFERENT OUTCOME IN THIS CASE. THE INVESTIGATION INDICATES THAT TYE SYSTEM WAS OPERATING NORMALLY AND WITHIN PERFORMANCE SPECIFICATIONS. THE INFO 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 THAT THE DEVICE DID NOT RECOGNIZE A VENTRICULAR TACHYCARDIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655622 SURVEYOR CENTRAL SURVEYOR CENTRAL MHX MORTARA INSTRUMENT, INC. SCSYS-EED-KBEAX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R