BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 3023891 · Received March 27, 2013

    Report

    Report Number
    2134265-2013-01950
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    OBJ
    PMA / PMN Number
    K051679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AGE AT THE TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR: THE PRODUCT WAS RECEIVED IN GOOD CONDITION WITH NO VISIBLE EXTERNAL DAMAGE OR DEFECTS OBSERVED. THE MDU WAS TESTED FOR FUNCTIONALITY AND WAS FOUND TO MEET SPECIFICATION. IN ADDITION TO THE FUNCTIONAL TEST, THE UNIT UNDERWENT A 4 HOUR BURN-IN WITHOUT ANY FAILURES OBSERVED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS NOT CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID # 2134265-2013-01951, 2134265-2013-01952. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION THE MOTOR DRIVE FAILED TO PULLBACK. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY. AN ATLANTIS SR PRO² INTRAVASCULAR CATHETER WAS USED TO DIAGNOSE THE LESION. DURING THE PROCEDURE, AUTOPULLBACK WAS FUNCTIONING WELL THEN SUDDENLY STOPPED. AFTER REBOOT, A CONNECTION ERROR OCCURRED. AFTER REBOOTING SEVERAL TIMES, THE SYSTEM AND THE MDU WERE ABLE TO FUNCTION WITHOUT ANY PROBLEM. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO PATIENT COMPLICATION REPORTED AND THE PATIENT'S CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125715 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB100CART0 0000006115

    Patients

    Seq Age Sex Outcome Treatment
    1