BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITE~RITE 8 ULTRASOUND SYSTEM CONSOLE WITH CONNECTOR

    MDR report key: 7834063 · Received August 30, 2018

    Report

    Report Number
    3006260740-2018-02287
    Event Type
    Malfunction
    Date Received
    August 30, 2018
    Report Date
    August 30, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    IYO
    UDI-DI
    00801741138263
    PMA / PMN Number
    K152554
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), APPLICABLE FMEA DOCUMENTS, LABELING, AND APPLICABLE MANUFACTURE RECORDS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE DEVICE WAS RETURNED TO THE SERVICE FACILITY FOR EVALUATION. DURING EVALUATION, THE REPORTED ISSUE OF THE IMAGE QUALITY IS POOR IS UNCONFIRMED. THE SCANNER WAS EVALUATED WITH THE MODEL 550 PHANTOM AND THE IMAGE WAS FOUND TO BE NORMAL FOR A SR 8 SCANNER WITH THE 20 MM GT PROBE. THE ROOT CAUSE OF THE REPORTED FAILURE IS INCONCLUSIVE AS THE REPORTED ISSUE COULD NOT BE REPRODUCED DURING EVALUATION. NO OTHER FUNCTIONALITY ISSUES WITH THE EQUIPMENT WERE FOUND DURING EVALUATION/SERVICING. THE DEVICE WAS SERVICED, TESTED AND RETURNED TO THE CUSTOMER. A HISTORY REVIEW OF SERIAL NUMBER (B)(6) SHOWED ONE OTHER SIMILAR COMPLAINT(S) FROM THIS SERIAL NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE BD SALES REP ON BEHALF OF THE ONCOLOGY DEPT OF THE HOSPITAL THAT THE SR 8 ULTRASOUND SYSTEM (9770600) IMAGE QUALITY IS POOR AND STATED AS 'VERY GRANULAR AND SCRAMBLED.' THE SALES REP STATED THEY ATTEMPTED TO TROUBLESHOOT BY CHANGING THE IMAGE FILTER SETTINGS AND OTHER IMAGE SETTINGS AS WELL AS IMAGING WITH AND WITHOUT A PROBE COVER AND WAS UNABLE TO IMPROVE THE IMAGE QUALITY.

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON. A HISTORY REVIEW OF SERIAL NUMBER (B)(4) SHOWED ONE OTHER SIMILAR COMPLAINT(S) FROM THIS SERIAL NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE BD SALES REP ON BEHALF OF THE ONCOLOGY DEPT OF THE HOSPITAL THAT THE SR 8 ULTRASOUND SYSTEM (9770600) IMAGE QUALITY IS POOR AND STATED AS 'VERY GRANULAR AND SCRAMBLED.' THE SALES REP STATED THEY ATTEMPTED TO TROUBLESHOOT BY CHANGING THE IMAGE FILTER SETTINGS AND OTHER IMAGE SETTINGS AS WELL AS IMAGING WITH AND WITHOUT A PROBE COVER AND WAS UNABLE TO IMPROVE THE IMAGE QUALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672419 SITE~RITE 8 ULTRASOUND SYSTEM CONSOLE WITH CONNECTOR SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BARD ACCESS SYSTEMS 9770600 00801741138263

    Patients

    Seq Age Sex Outcome Treatment
    1