BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 3841410 · Received May 30, 2014

    Report

    Report Number
    2134265-2014-03226
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Report Date
    May 14, 2014
    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: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR: 2134265-2014-03331; 2134265-2014-03332. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. DURING PROCEDURE, A 100V ILAB CART ULTRASOUND IMAGING SYSTEM WAS USED IN CONJUNCTION WITH AN OPTICROSS IMAGING CATHETER. AFTER IMAGE WAS DISPLAYED, THE PHYSICIAN TRIED TO PERFORM PULLBACK HOWEVER IT FAILED TO PERFORM AUTOMATIC PULLBACK. NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318007 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB100CART0 0000005916

    Patients

    Seq Age Sex Outcome Treatment
    1