BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 2945083 · Received February 6, 2013

    Report

    Report Number
    2134265-2013-00319
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Report Date
    January 8, 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). DEVICE EVALUATED BY MFR: EXAMINATION OF THE RETURNED DEVICE OBSERVED WITH NO VISIBLE DAMAGE OR DEFECTS. THE DEVICE MEETS SPECIFICATIONS FOR FUNCTIONAL TEST AND SUCCESSFULLY UNDERWENT A CONTINUOUS BURN-IN FOR 4 HOURS. THE REPORTED PROBLEM COULD NOT BE REPRODUCED AS INDICATED IN THE COMPLAINT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID # 2134265-2013-00335, 2134265-2013-00334. IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, THE AUTOMATIC PULLBACK OF ILAB MOTORDRIVE DID NOT WORK WHEN USED WITH A BSC SLED AND ATLANTIS SR PRO² IMAGING CATHETER. THE PROCEDURE WAS COMPLETED USING THE MANUAL PULLBACK. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50350 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB100CART0

    Patients

    Seq Age Sex Outcome Treatment
    1