BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURVEYOR CENTRAL

    MDR report key: 5506902 · Received March 17, 2016

    Report

    Report Number
    2183461-2016-00003
    Event Type
    Injury
    Date Received
    March 17, 2016
    Date of Event
    February 11, 2016
    Report Date
    March 17, 2016
    Manufacturer
    MORTARA INSTRUMENT, INC.
    Product Code
    MHX
    PMA / PMN Number
    K060135
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYSTEM LOG FILES WERE REVIEWED. EVENT INVOLVED A PATIENT WITH AN IMPLANTED DEFIBRILLATOR AND PACED WITH A DUAL CHAMBER PACEMAKER AT A FIXED RATE OF 80 BPM. THE VENTRICULAR TACHYCARDIA LIMITS WERE SET AT 8 BEATS, 120 BPM. HIGH HEART RATE LIMIT WAS SET AT 150 BPM. THERE WERE FREQUENT EPISODES OF SHORT VENTRICULAR RUNS; TWO WERE LONGER THAN THE SET LIMITS AND REPORTED AS VT ALARMS. VT ALARMS WERE GENERATED FOR FOUR SIMILAR SERIES OF VT'S (9:05:10, 9:07:12, 9:11:52, 9:14:13). AT 9:14, THE USER DISABLED THE VT ALARM, LEAVING ONLY THE "SUSTAINED VT" ALARM ACTIVE AS IT CANNOT BE DISABLED. THE FOLLOWING DAY AT 7:46:35 ANOTHER VT OCCURRED; THE BEATS WERE CLASSIFIED BY SURVEYOR AS VENTRICULAR AND A HIGH HEART RATE >150 BPM WAS GIVEN, SINCE THE VT ALARM WAS DISABLED. THIS REPEATED AT 10:08:44, 10:10:30, 12:46:59, 12:47:27, 14:03:04. AT 23:54 THE EVENTS BECAME MORE FREQUENT AND LONGER. AT 23:56:30 A VT WAS TERMINATED BY OVER-PACING. AT 00:13:19 A LONGER VT WAS TERMINATED BY A DEFIBRILLATION SHOCK; THIS WAS THE LONGEST CONTINUOUS VT, 26 SECONDS LONG. AT 00:16, SHORTLY AFTER THE LONG VT'S, THE USER CHANGED THE VT ALARM LIMIT TO 5 BEATS, 110 BPM, BUT LEFT THE VT ALARM DISABLED. THE REASON A VENTRICULAR TACHYCARDIA ALARM WAS NOT GENERATED IS THAT THE USER DISABLED IT. THERE WERE NO VT'S THAT LASTED LONGER THAN 30 SECONDS; THEREFORE NO "SUSTAINED VT" ALARM WAS GENERATED. 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. HOWEVER, THE PATIENT'S IMPLANTABLE DEFIBRILLATOR DID DISCHARGE DURING THE EVENT AND INTERVENED TO PRESUMABLY PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION. THE SURVEYOR CENTRAL WAS, OR MAY HAVE BEEN, A FACTOR IN THE EVENT AS A RESULT OF USER ERROR WHEN THE USER DISABLED THE VENTRICULAR TACHYCARDIA ALARM. THE INVESTIGATION IS COMPLETE AND NO FURTHER ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SURVEYOR SYSTEM FAILED TO DETECT A VENTRICULAR TACHYCARDIA. THE PATIENT'S IMPLANTABLE PACEMAKER AND DEFIBRILLATOR DISCHARGED DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162955 SURVEYOR CENTRAL SURVEYOR CENTRAL MHX MORTARA INSTRUMENT, INC. SCSYS-EED-RBEAX

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R