BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 3971342 · Received July 31, 2014

    Report

    Report Number
    2134265-2014-04501
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Report Date
    July 8, 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: 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).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE PRODUCT WAS RECEIVED IN GOOD CONDITION. THE UNIT PASSED THE MDU-5 PLUS BASIC FUNCTIONAL TEST. NO ERROR MESSAGES WERE OBSERVED DURING THE TEST. IN ADDITION, THE UNIT SUCCESSFULLY UNDERWENT A CONTINUOUS BURN-IN FOR 7 HOURS. 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: 2134265-2014-04617, 2134265-2014-04618. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. DURING PREPARATION FOR PERCUTANEOUS CORONARY INTERVENTION (PCI), IT WAS NOTED THAT THE AUTOMATIC PULLBACK WAS NOT WORKING. THE BSC IMAGING CATHETER WAS CHANGED THEN A SIMULATOR WAS USED AND THE SYSTEM WAS REBOOTED, HOWEVER, THE PROBLEM WAS NOT RESOLVED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2014-04617, 2134265-2014-04618. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. DURING PREPARATION FOR PERCUTANEOUS CORONARY INTERVENTION (PCI), IT WAS NOTED THAT THE AUTOMATIC PULLBACK WAS NOT WORKING. THE BSC IMAGING CATHETER WAS CHANGED THEN A SIMULATOR WAS USED AND THE SYSTEM WAS REBOOTED, HOWEVER, THE PROBLEM WAS NOT RESOLVED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448357 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB100INS0 0000005162

    Patients

    Seq Age Sex Outcome Treatment
    1