BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 3101471 · Received May 9, 2013

    Report

    Report Number
    2134265-2013-03177
    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).

    Additional Manufacturer Narrative · 1

    DEVICE EVAL BY MFT: THE DEVICE WAS RETURNED FOR ANALYSIS IN GOOD CONDITION WITH NO VISIBLE EXTERNAL DAMAGE OR DEFECTS OBSERVED. THE UNIT WAS INSTALLED INTO A GOLD STANDARD SYSTEM AND TESTED FOR FUNCTIONALITY AND HAS MEET SPECIFICATIONS. IT ALSO 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 ROOT CAUSE IS UNABLE TO BE CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID # 2134265-2013-03167 AND MDR ID # 2134265-2013-03284. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION TREATMENT PROCEDURE, THE ILAB ULTRASOUND IMAGING SYSTEM MOTORDRIVE WAS UNABLE TO PERFORM PULLBACK. DURING A PERCUTANEOUS CORONARY INTERVENTION TREATMENT PROCEDURE, IT WAS NOTED THAT THE MDU OF THE ILAB IMAGING SYSTEM WAS NOT ABLE TO PERFORM PULLBACK. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE THROUGH MANUAL PULLBACK. THERE WERE NO REPORTED COMPLICATIONS AND THE PATIENT STATUS POST PROCEDURE WAS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID # 2134265-2013-03167 AND MDR ID # 2134265-2013-03284. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION TREATMENT PROCEDURE, THE ILAB ULTRASOUND IMAGING SYSTEM MOTORDRIVE WAS UNABLE TO PERFORM PULLBACK. DURING A PERCUTANEOUS CORONARY INTERVENTION TREATMENT PROCEDURE, IT WAS NOTED THAT THE MDU OF THE ILAB IMAGING SYSTEM WAS NOT ABLE TO PERFORM PULLBACK. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE THROUGH MANUAL PULLBACK. THERE WERE NO REPORTED COMPLICATIONS AND THE PATIENT STATUS POST PROCEDURE WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204080 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB100CART0 7459

    Patients

    Seq Age Sex Outcome Treatment
    1