BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 4090133 · Received September 15, 2014

    Report

    Report Number
    2134265-2014-05463
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 19, 2014
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    OBJ
    PMA / PMN Number
    K051679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. THE UNIT WAS RECEIVED IN GOOD CONDITION WITH NO VISIBLE DAMAGE OR DEFECTS OBSERVED. FUNCTIONAL TESTING REVEALED THAT THE DEVICE MEETS SPECIFICATIONS. IN ADDITION, THE UNIT SUCCESSFULLY UNDERWENT A CONTINUOUS BURN-IN OVERNIGHT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2014-05469 AND 2134265-2014-05567. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. DURING THE PROCEDURE AN ILAB IMAGING SYSTEM WAS USED. IT WAS NOTED THAT THE MOTOR DRIVE UNIT (MDU) FAILED TO PERFORM AUTOMATIC PULLBACK WITH NORMAL LCD DISPLAY. AUTOMATIC PULLBACK WAS ATTEMPTED FOUR TIMES BUT UNSUCCESSFUL. SLED REPLACEMENT DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED WITH MANUAL PULLBACK USING THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2014-05469 AND 2134265-2014-05567. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. DURING THE PROCEDURE AN ILAB IMAGING SYSTEM WAS USED. IT WAS NOTED THAT THE MOTOR DRIVE UNIT (MDU) FAILED TO PERFORM AUTOMATIC PULLBACK WITH NORMAL LCD DISPLAY. AUTOMATIC PULLBACK WAS ATTEMPTED FOUR TIMES BUT UNSUCCESSFUL. SLED REPLACEMENT DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED WITH MANUAL PULLBACK USING THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569831 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB120CART0 0000005347

    Patients

    Seq Age Sex Outcome Treatment
    1