BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 3122694 · Received May 21, 2013

    Report

    Report Number
    2134265-2013-03528
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    OBJ
    PMA / PMN Number
    K051679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    THE UNIT WAS RETURNED FOR EVALUATION. THE LCD DISPLAY COVER WAS DAMAGED. THE UNIT MEETS ITS SPECIFICATIONS DURING FUNCTIONAL TEST AND SUCCESSFULLY UNDERWENT A CONTINUOUS BURN-IN OVERNIGHT. 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 AS MDR ID # 2134265-2013-03530 AND MDR ID # 2134265-2013-03529. IT WAS REPORTED THAT DURING A CORONARY INTERVENTION, AN AUTOMATIC PULLBACK FAILURE OCCURRED. DURING THE PROCEDURE, THE MDU WAS UNABLE TO PERFORM AUTO PULLBACK. THE PHYSICIAN DID THE MANUAL PULLBACK AND COMPLETE THE PROCEDURE.

    Description of Event or Problem · 1

    SAME AS MDR ID # 2134265-2013-03530 AND MDR ID # 2134265-2013-03529. IT WAS REPORTED THAT DURING A CORONARY INTERVENTION, AN AUTOMATIC PULLBACK FAILURE OCCURRED. DURING THE PROCEDURE, THE MDU WAS UNABLE TO PERFORM AUTO PULLBACK. THE PHYSICIAN DID THE MANUAL PULLBACK AND COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223945 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB240INS0 6207

    Patients

    Seq Age Sex Outcome Treatment
    1