BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 3884651 · Received June 19, 2014

    Report

    Report Number
    2134265-2014-03811
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Report Date
    July 31, 2014
    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

    DEVICE EVALUATED BY MFR.: THE PRODUCT WAS RECEIVED IN GOOD CONDITION. THE UNIT PASSED THE MOTORDRIVE UNIT-5 PLUS BASIC FUNCTIONAL TEST. NO ERROR MESSAGES WERE OBSERVED DURING THE TEST. IN ADDITION, THE UNIT SUCCESSFULLY UNDERWENT A CONTENTIOUS 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).

    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).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2014-03934 AND 2134265-2014-03933. IT WAS REPORTED THAT MOTOR DRIVE UNIT DOES NOT PULLBACK. THE ILAB MOTOR DRIVE UNIT WAS USED IN CONJUNCTION WITH A BSC CORONARY CATHETER INTENDED TO VISUALIZE THE LESION. IT WAS NOTED THAT DURING PROCEDURE, MOTOR DRIVE UNIT DOES NOT PULLBACK. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2014-03934 AND 2134265-2014-03933. IT WAS REPORTED THAT MOTOR DRIVE UNIT DOES NOT PULLBACK. THE ILAB MOTOR DRIVE UNIT WAS USED IN CONJUNCTION WITH A BSC CORONARY CATHETER INTENDED TO VISUALIZE THE LESION. IT WAS NOTED THAT DURING PROCEDURE, MOTOR DRIVE UNIT DOES NOT PULLBACK. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361514 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB100CART0 6466

    Patients

    Seq Age Sex Outcome Treatment
    1