BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 3941995 · Received July 17, 2014

    Report

    Report Number
    2134265-2014-04107
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    June 19, 2014
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    OBJ
    PMA / PMN Number
    K051679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE UNIT WAS RECEIVED IN GOOD CONDITION WITH NO VISIBLE DAMAGE OR DEFECTS OBSERVED. THE UNIT DOES NOT MEET SPECIFICATIONS FOR FUNCTIONAL TEST. THE ROOT CAUSE OF FAILURE IS A DEFECTIVE BACKPLANE PCA BOARD. BY REPLACING THE DEFECTIVE BACKPLANE PCA BOARD WITH A KNOWN GOOD BACKPLANE PCA BOARD THE CATHETER IS ABLE TO BE IDENTIFIED, THE PULLBACK WORK AND THE DISPLAY DOES ILLUMINATE. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE HAS BEEN DETERMINED TO BE WEAR AND TEAR. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID # 2134265-2014-04130 AND 2134265-2014-04129. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. DURING PREPARATION FOR PERCUTANEOUS CORONARY INTERVENTION (PCI), IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. ALSO, IT WAS NOTED THAT THE DISPLAY DID NOT ILLUMINATE AND THE BSC IMAGING CATHETER WAS NOT IDENTIFIED. NO PATIENT INJURY OR COMPLICATIONS REPORTED.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID # 2134265-2014-04130 AND 2134265-2014-04129. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. DURING PREPARATION FOR PERCUTANEOUS CORONARY INTERVENTION (PCI), IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. ALSO, IT WAS NOTED THAT THE DISPLAY DID NOT ILLUMINATE AND THE BSC IMAGING CATHETER WAS NOT IDENTIFIED. NO PATIENT INJURY OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418093 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) UNK71

    Patients

    Seq Age Sex Outcome Treatment
    1