BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 2925560 · Received January 22, 2013

    Report

    Report Number
    2134265-2012-08545
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    December 26, 2012
    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

    (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 WITH NO VISIBLE EXTERNAL DAMAGE OR DEFECTS OBSERVED. THE MDU-5 WAS INSTALLED INTO A GOLD STANDARD SYSTEM AND TESTED FOR FUNCTIONALITY. 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).

    Description of Event or Problem · 1

    SAME CASE AS MFR #: 2134265-2013-00100 AND 2134265-2013-00101. IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE THE MOTOR DRIVE WAS UNABLE TO PERFORM PULLBACK. THE TARGET LESION WAS LOCATED IN AN UNKNOWN VESSEL. THE MOTOR DRIVE WAS UNABLE TO PERFORM PULLBACK AND DID NOT DISPLAY AN ERROR MESSAGE. THE EVENT OCCURRED OUTSIDE OF THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    SAME CASE AS MFR #: 2134265-2013-00100 AND 2134265-2013-00101. IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE THE MOTOR DRIVE WAS UNABLE TO PERFORM PULLBACK. THE TARGET LESION WAS LOCATED IN AN UNKNOWN VESSEL. THE MOTOR DRIVE WAS UNABLE TO PERFORM PULLBACK AND DID NOT DISPLAY AN ERROR MESSAGE. THE EVENT OCCURRED OUTSIDE OF THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29960 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB100CART0

    Patients

    Seq Age Sex Outcome Treatment
    1