BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 3101793 · Received May 9, 2013

    Report

    Report Number
    2134265-2013-03176
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 10, 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: DEVICE NOT RECEIVED FOR ANALYSIS. THE SERIAL NUMBER FOR THE MOTOR DRIVE IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS DESIGN RELATED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID #: 2134265-2013-03270 AND 2134265-2013-03270. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, PULLBACK WAS SUDDENLY STOPPED. THE ILAB CART SYSTEM 100V MOTOR DRIVE UNIT (MDU) WAS USED IN CONJUNCTION WITH THE CORONARY CATHETER INTENDED TO VISUALIZE THE LESION. THE PULLBACK WAS SUDDENLY STOPPED AND AN ERROR MESSAGE WAS DISPLAYED ON THE MONITOR. AFTER PRESSING THE OK BUTTON, THE SYSTEM WAS REBOOTED UP. THE SYSTEM WAS RUNNING WITH NO ISSUE AFTER REBOOTING UP. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO COMPLICATIONS REPORTED. THE PATIENT'S CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203102 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB100CART0 0000006595

    Patients

    Seq Age Sex Outcome Treatment
    1