BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 4181327 · Received October 17, 2014

    Report

    Report Number
    2134265-2014-06419
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 24, 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

    AGE AT TIME OF EVENT: UNDER 18 YEARS. (B)(4). THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW OF ILAB SYSTEM CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MDU BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR MDU COULD NOT BE REVIEWED. THE CAUSE OF THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2014-06420, 2134265-2014-06421. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. AN ILAB ULTRASOUND IMAGING SYSTEM WAS USED IN CONJUNCTION WITH AN OPTICROSS¿ IMAGING CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED AUTOMATIC PULLBACK AND IMAGE WAS ABLE TO APPEAR BUT THE MOTOR DRIVE STOPPED DURING PULLBACK. NO PATIENT COMPLICATIONS REPORTED AND PATIENT'S CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660583 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB100CART0 0000005232

    Patients

    Seq Age Sex Outcome Treatment
    1