BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 2962543 · Received February 14, 2013

    Report

    Report Number
    2134265-2013-00645
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    January 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    OBJ
    PMA / PMN Number
    K051679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE PRODUCT WAS RECEIVED IN GOOD CONDITION WITH NO VISIBLE EXTERNAL DAMAGE OR DEFECTS OBSERVED. THE MDU-5 WAS INSTALLED INTO A GOLD STANDARD SYSTEM AND TESTED FOR FUNCTIONALITY. THE UNIT UNDERWENT A 4 HOUR BURN-IN WITHOUT ANY FAILURES OBSERVED. THE UNIT MEETS SPECIFICATIONS. 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

    (B)(4). DEVICE EVALUATED BY MFR: 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).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID # 2134265-2013-0064, 2134265-2013-00647. IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, THE AUTOMATIC PULLBACK OF THE ILAB MOTORDRIVE STOPPED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID # 2134265-2013-0064, 2134265-2013-00647. IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, THE AUTOMATIC PULLBACK OF THE ILAB MOTORDRIVE STOPPED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65930 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - MAPLE GROVE H749ILAB100CART0

    Patients

    Seq Age Sex Outcome Treatment
    1