BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 2920184 · Received January 17, 2013

    Report

    Report Number
    2134265-2012-08542
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE UNIT WAS RECEIVED IN GOOD CONDITION WITH NO VISIBLE DAMAGE OR DEFECTS OBSERVED. THE UNIT MEETS SPECIFICATIONS FOR FUNCTIONAL TEST. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE OF MFR #: 2134265-2013-00337 AND 2134265-2013-00338 IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE MOTOR DRIVE UNIT FAILED TO PULLBACK. THE TARGET LESION WAS LOCATED IN AN UNKNOWN VESSEL. THE MOTOR DRIVE UNIT WAS ATTACHED TO THE SLED, AUTOMATIC PULLBACK WAS ATTEMPTED AND FAILED. THE MOTOR DRIVE UNIT WAS ATTACHED TO A SECOND SLED, AUTOMATIC PULLBACK WAS ATTEMPTED AND FAILED. THE MOTOR DRIVE UNIT WAS EXCHANGED FOR ANOTHER, ATTACHED TO THE SAME SLED AND PULLBACK WAS SUCCESSFUL. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26009 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB120INS0

    Patients

    Seq Age Sex Outcome Treatment
    1