BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 3942051 · Received July 17, 2014

    Report

    Report Number
    2134265-2014-04290
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    June 27, 2014
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    OBJ
    PMA / PMN Number
    K051679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE UNIT WAS RECEIVED IN GOOD CONDITION WITH NO VISIBLE DAMAGE OR DEFECTS OBSERVED. THE UNIT MEETS SPECIFICATIONS FOR MOTORDRIVE UNIT -5 QC FUNCTIONAL TEST. THE UNIT SUCCESSFULLY UNDERWENT A CONTINUOUS BURN-IN FOR OVERNIGHT. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS : 2134265-2014-04489 AND 2134265-2014-04488. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. THE ILAB MOTOR DRIVE UNIT WAS USED IN CONJUNCTION WITH A BSC CORONARY CATHETER INTENDED TO VISUALIZE THE UNSPECIFIED LESION. DURING PROCEDURE, AUTOMATIC PULLBACK DID NOT WORK. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    SAME CASE AS : 2134265-2014-04489 AND 2134265-2014-04488. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. THE ILAB MOTOR DRIVE UNIT WAS USED IN CONJUNCTION WITH A BSC CORONARY CATHETER INTENDED TO VISUALIZE THE UNSPECIFIED LESION. DURING PROCEDURE, AUTOMATIC PULLBACK DID NOT WORK. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418695 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) UNK71

    Patients

    Seq Age Sex Outcome Treatment
    1