BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURVEYOR CENTRAL

    MDR report key: 5460257 · Received February 25, 2016

    Report

    Report Number
    2183461-2016-00001
    Event Type
    Death
    Date Received
    February 25, 2016
    Date of Event
    December 30, 2015
    Report Date
    February 25, 2016
    Manufacturer
    MORTARA INSTRUMENT, INC
    Product Code
    MHX
    PMA / PMN Number
    K060135
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM LOG FILES AND AUDIT TRAIL WERE REVIEWED AND IDENTIFIED THE SURVEYOR SYSTEM FUNCTIONED NORMALLY, AND THAT ALARMS WERE ACTIVE AT THE MOMENT OF THE EVENT. AT 22:13:17 THE ECG SIGNAL WAS INTERRUPTED AND A "NO ECG MONITORING" ALARM WAS GENERATED. AT 22:15:21 HOSPITAL PERSONNEL SILENCED THE ALARMS FOR "NO RADIO SIGNAL" AND "NO ECG MONITORING". PATIENT WAS DISCHARGED (MONITORING INTERRUPTED) BY PERSONNEL AT 23:05:13. THE PATIENT WAS FOUND LYING ON THE FLOOR, AND THE BODY OF THE PATIENT SHIELDED THE TRANSMITTER CAUSING THE ECG SIGNAL INTERRUPTION. THE PRINTOUTS OF THE EVENT WERE REVIEWED. THE SYSTEM DID NOT DETECT ALL BEATS DURING THE TORSADES DE POINTES BECAUSE OF THE TYPICAL LOW SLEW RATE OF THE WAVES AND THE HEART RATE MEASURED BY THE PROGRAM DID NOT REACH MORE THAN 130 BPM. SOME BEATS WERE CLASSIFIED AS VENTRICULAR AND SOME WERE NOT BECAUSE OF THE IRREGULAR TIME AND SHAPE OF THE DETECTED BEATS. DURING THE TORSADES DE POINTES EVENT, THE SYSTEM CLASSIFIED 6 BEATS AS VENTRICULAR AND THEN THE ECG SIGNAL WAS INTERRUPTED. ACCORDING TO THE CUSTOMER, THE THRESHOLD FOR A VENTRICULAR TACHYCARDIA ALARM WAS SET AT 10 BEATS, 120 BPM. THE ECG PRINTOUTS SHOW THE PATIENT HAD A VERY PROLONGED QT-DURATION, WHICH IS A RISK FACTOR FOR TORSADES DE POINTES. 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. WITHIN THE WARNING SECTION OF THE USER MANUAL, THE OPERATOR IS INSTRUCTED TO CHECK VARIOUS ALARM SETTINGS AFTER EACH PATIENT ADMISSION TO ENSURE WHETHER THE CHOSEN ALARM LIMITS ARE APPROPRIATE FOR THE INDIVIDUAL PATIENT. IT IS GOOD CLINICAL PRACTICE TO TIGHTEN THE LIMITS FOR VENTRICULAR TACHYCARDIA AND HEART RATE AND HAVE THE PATIENT MORE CLOSELY WATCHED WHEN EXHIBITING CERTAIN RISK FACTORS. THE INVESTIGATION IS COMPLETE AND NO FURTHER ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A TORSADES DE POINTES (TDP) HEART RHYTHM WAS NOT RECOGNIZED BY THE SYSTEM. THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118781 SURVEYOR CENTRAL SURVEYOR CENTRAL MHX MORTARA INSTRUMENT, INC SCSYS-EED-FBFAX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death