BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 3770816 · Received April 24, 2014

    Report

    Report Number
    2134265-2014-02371
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Report Date
    April 8, 2014
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    OBJ
    PMA / PMN Number
    K051679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. 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 RETURNED FOR ANALYSIS. THE UNIT WAS RECEIVED IN GOOD CONDITION WITH NO VISIBLE DAMAGE OR DEFECTS OBSERVED. THE MDU-5 PLUS UNIT FAILED THE MDU-5 PLUS BASIC FUNCTIONAL TEST. THE MOTOR DRIVE'S PULLBACK FEATURE WAS FUNCTIONAL. HOWEVER, IT FAILED TO PRODUCE A CLEAR IMAGE. THE CAUSE OF THE FAILURE IS A DEFECTIVE LEMO CABLE DUE TO A SUPPLIER ISSUE. 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 MDR ID # 2134265-2014-02481 AND 2134265-2014-02480. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. THE MOTOR DRIVE UNIT WAS USED IN CONJUNCTION WITH AN IMAGING CATHETER AND SLED. IT WAS NOTED THAT THE MOTOR DRIVE UNIT(MDU) AUTOMATIC PULLBACK STOPPED AS SOON AS THEY PUSHED THE PULL BACK BUTTON. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID # 2134265-2014-02481 AND 2134265-2014-02480. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. THE MOTOR DRIVE UNIT WAS USED IN CONJUNCTION WITH AN IMAGING CATHETER AND SLED. IT WAS NOTED THAT THE MOTOR DRIVE UNIT(MDU) AUTOMATIC PULLBACK STOPPED AS SOON AS THEY PUSHED THE PULL BACK BUTTON. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249219 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB100CART0 5836

    Patients

    Seq Age Sex Outcome Treatment
    1