BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 3429499 · Received October 25, 2013

    Report

    Report Number
    2134265-2013-07696
    Event Type
    Malfunction
    Date Received
    October 25, 2013
    Report Date
    October 2, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    OBJ
    PMA / PMN Number
    K051679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RECEIVED FOR EVALUATION IN GOOD CONDITION. FUNCTIONAL TESTING REVEALED THAT THE DEVICE MEET SPECIFICATIONS AND NO ERROR MESSAGES WERE OBSERVED. IN ADDITION, THE UNIT SUCCESSFULLY UNDERWENT A CONTINUOUS BURN-IN OVERNIGHT WITHOUT ANY FAILURES. 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: 2134265-2013-07696, 2134265-2013-07642. IT WAS REPORTED THAT THE MDU GOT FROZEN DURING AUTOMATIC PULLBACK. THE MOTOR DRIVE UNIT (MDU) WAS USED IN CONJUNCTION WITH THE IMAGING CATHETER TO VISUALIZE THE LESION. THE CATHETER WAS CONNECTED TO THE MDU AND "CATHETER CONNECTED" MESSAGE WAS DISPLAYED. THE PHYSICIAN THEN NOTICED THAT THE MDU GOT FROZEN. THE DEVICE WAS REBOOTED UP, BUT DURING AUTOMATIC PULLBACK THE DEVICE GOT FROZEN. MANUAL PULLBACK WAS PERFORMED WITH NO ISSUES. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2013-07696, 2134265-2013-07642. IT WAS REPORTED THAT THE MDU GOT FROZEN DURING AUTOMATIC PULLBACK. THE MOTOR DRIVE UNIT (MDU) WAS USED IN CONJUNCTION WITH THE IMAGING CATHETER TO VISUALIZE THE LESION. THE CATHETER WAS CONNECTED TO THE MDU AND "CATHETER CONNECTED" MESSAGE WAS DISPLAYED. THE PHYSICIAN THEN NOTICED THAT THE MDU GOT FROZEN. THE DEVICE WAS REBOOTED UP, BUT DURING AUTOMATIC PULLBACK THE DEVICE GOT FROZEN. MANUAL PULLBACK WAS PERFORMED WITH NO ISSUES. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549133 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB100INS0 0000007283

    Patients

    Seq Age Sex Outcome Treatment
    1