BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURVEYOR CENTRAL

    MDR report key: 5130849 · Received October 2, 2015

    Report

    Report Number
    2183461-2015-00004
    Event Type
    Injury
    Date Received
    October 2, 2015
    Date of Event
    August 7, 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 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 INVOLVED A PATIENT W/A DUAL-CHAMBER PACEMAKER WHERE MOST QRS-COMPLEXES ARE PACED AND WIDE; RECOGNIZED AS "PACED" COMPLEXES. VARIOUS EVENTS WERE CORRECTLY RECOGNIZED BY THE SYSTEM; ONE EVENT WAS NOT RECOGNIZED BECAUSE THE SIGNAL WAS INTERRUPTED, PRESUMABLY BY THE PACEMAKER, AND THE VFIB ENDED BEFORE THERE WAS ENOUGH DATA TO ANALYZE. THE INVESTIGATION INDICATES THAT THE 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 CENTRAL DID NOT RECOGNIZE A VENTRICULAR FIBRILLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656257 SURVEYOR CENTRAL SURVEYOR CENTRAL MHX MORTARA INSTRUMENT, INC. SCSYS-BED-QBFAX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R