BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM, VERSION 1.3

    MDR report key: 3180545 · Received June 20, 2013

    Report

    Report Number
    2134265-2013-04554
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    IYO
    PMA / PMN Number
    K072517
    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: THE PRODUCT WAS RECEIVED IN GOOD CONDITION WITH NO VISIBLE EXTERNAL DAMAGE OR DEFECTS OBSERVED. THE UNIT WAS TESTED FOR FUNCTIONALITY AND MET SPECIFICATIONS; AND THE UNIT UNDERWENT A 4 HOUR BURN-IN WITHOUT ANY FAILURES OBSERVED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS NOT CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID #2134265-2013-04553 AND MDR ID #2134265-2013-04555. IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION, MOTOR DRIVE UNIT WAS UNABLE TO PERFORM PULLBACK. THE PHYSICIAN USED AN ILAB SYSTEM WITH AN ATLANTIS SR PRO² CATHETER TO IMAGE AN UNSPECIFIED VESSEL. THE IMAGE WAS LOST AND THE MDU HAD NO DISPLAY. THEY PERFORMED AUTO PULLBACK ONCE AND REBOOTED THE SYSTEM UP, HOWEVER THE ISSUE WAS NOT SOLVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280220 ILAB ULTRASOUND IMAGING SYSTEM, VERSION 1.3 SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB100CARTD0 0000005177

    Patients

    Seq Age Sex Outcome Treatment
    1