BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 3122932 · Received May 21, 2013

    Report

    Report Number
    2134265-2013-03743
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    OBJ
    PMA / PMN Number
    K051679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE UNIT WAS RECEIVED WITH A DAMAGE LCD DISPLAY COVER. THE UNIT MET SPECIFICATIONS DURING FUNCTIONAL TEST AND SUCCESSFULLY UNDERWENT A CONTINUOUS BURN-IN OVERNIGHT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS NOT CONFIRMED. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OF AGE OR OVER. COMPLAINANT NAME: HOSPITAL UNIV. (B)(6). (B)(4).

    Description of Event or Problem · 1

    SAME AS MDR ID # 2134265-2013-03744 AND 2134265-2013-03745. IT WAS REPORTED THAT DURING INTRAVASCULAR ULTRASOUND, AN AUTOMATIC PULLBACK BUTTON DOESN'T WORK. THE PHYSICIAN USED AN ILAB CART SYSTEM 240V MOTOR DRIVE UNIT IN CONJUNCTION WITH A BSC CORONARY IMAGING CATHETER AND ASSY SLED PULLBACK SINGLE PACK MD5 TO IMAGE AN UNSPECIFIED VESSEL. DURING THE PROCEDURE, THE MOTOR DRIVE UNIT'S AUTOMATIC PULLBACK BUTTON WOULD NOT WORK. THEY COMPLETED THE PROCEDURE USING THE TOUCH CONTROL PANEL AUTOMATIC PULLBACK. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    SAME AS MDR ID # 2134265-2013-03744 AND 2134265-2013-03745. IT WAS REPORTED THAT DURING INTRAVASCULAR ULTRASOUND, AN AUTOMATIC PULLBACK BUTTON DOESN'T WORK. THE PHYSICIAN USED AN ILAB CART SYSTEM 240V MOTOR DRIVE UNIT IN CONJUNCTION WITH A BSC CORONARY IMAGING CATHETER AND ASSY SLED PULLBACK SINGLE PACK MD5 TO IMAGE AN UNSPECIFIED VESSEL. DURING THE PROCEDURE, THE MOTOR DRIVE UNIT'S AUTOMATIC PULLBACK BUTTON WOULD NOT WORK. THEY COMPLETED THE PROCEDURE USING THE TOUCH CONTROL PANEL AUTOMATIC PULLBACK. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224133 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB240INS0

    Patients

    Seq Age Sex Outcome Treatment
    1