BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 4411055 · Received January 13, 2015

    Report

    Report Number
    2134265-2014-08269
    Event Type
    Malfunction
    Date Received
    January 13, 2015
    Date of Event
    December 15, 2014
    Report Date
    December 15, 2014
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    OBJ
    PMA / PMN Number
    K051679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. THE PRODUCT WAS RECEIVED IN GOOD CONDITION. THE UNIT MEETS SPECIFICATIONS FOR FUNCTIONAL TEST. IN ADDITION, THE UNIT SUCCESSFULLY UNDERWENT A CONTINUOUS BURN-IN OVERNIGHT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2014-08449, 2134265-2014-08450. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. IT WAS NOTED THAT THE MOTOR DRIVE UNIT (MDU) OF AN ILAB ULTRASOUND IMAGING SYSTEM WAS NOT PULLING BACK. THE LCD DISPLAY WAS NORMAL. THE MDU WAS THEN CHANGED WITH A DIFFERENT MDU AND THEN IT WORKED FINE. NO PATIENT INVOLVEMENT WAS REPORTED.

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2014-08449, 2134265-2014-08450. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. IT WAS NOTED THAT THE MOTOR DRIVE UNIT (MDU) OF AN ILAB ULTRASOUND IMAGING SYSTEM WAS NOT PULLING BACK. THE LCD DISPLAY WAS NORMAL. THE MDU WAS THEN CHANGED WITH A DIFFERENT MDU AND THEN IT WORKED FINE. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28226 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB120CART0 0000004415

    Patients

    Seq Age Sex Outcome Treatment
    1