BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 3953324 · Received July 23, 2014

    Report

    Report Number
    2134265-2014-04515
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    OBJ
    PMA / PMN Number
    K051679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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. THE UNIT MEETS SPECIFICATIONS FOR MDU-5 QC FUNCTIONAL TEST. THE RESULTS WERE RECORDED ON THE MDU-5 QC FUNCTIONAL TEST DATA SHEET. IN ADDITION, THE UNIT SUCCESSFULLY UNDERWENT A CONTINUOUS BURN-IN FOR 4 HOURS. 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).

    Description of Event or Problem · 1

    SAME CASES AS MDR ID 212134265-2014-04427 AND 2134265-2014-04428. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. A 120V ILAB INSTALLATION BASIC ULTRASOUND IMAGING SYSTEM WAS USED IN CONJUNCTION WITH AN UNSPECIFIED BSC IMAGING CATHETER IN AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO PERFORM PULLBACK THREE TIMES BUT AUTOMATIC PULLBACK FAILED. THE PROCEDURE WAS COMPLETED USING MANUAL PULLBACK. NO PATIENT INVOLVEMENT REPORTED.

    Description of Event or Problem · 1

    SAME CASES AS MDR ID 212134265-2014-04427 AND 2134265-2014-04428. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. A 120V ILAB INSTALLATION BASIC ULTRASOUND IMAGING SYSTEM WAS USED IN CONJUNCTION WITH AN UNSPECIFIED BSC IMAGING CATHETER IN AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO PERFORM PULLBACK THREE TIMES BUT AUTOMATIC PULLBACK FAILED. THE PROCEDURE WAS COMPLETED USING MANUAL PULLBACK. NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431142 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB120INS0 0000004567

    Patients

    Seq Age Sex Outcome Treatment
    1