BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITE~RITE 8 ULTRASOUND SYSTEM CONSOLE WITH CONNECTOR

    MDR report key: 7899066 · Received September 21, 2018

    Report

    Report Number
    3006260740-2018-02541
    Event Type
    Malfunction
    Date Received
    September 21, 2018
    Report Date
    September 21, 2018
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    IYO
    UDI-DI
    00801741138263
    PMA / PMN Number
    K152554
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    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 DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A HISTORY REVIEW OF SERIAL NUMBER (B)(4) SHOWED NO OTHER SIMILAR COMPLAINT(S) FROM THIS SERIAL NUMBER.

    Description of Event or Problem · 1

    VAT NURSE REPORTED THAT SITE RITE 8 ULTRASOUND SYSTEM (9770600) HAS A 2 SECOND LAG IN THE IMAGE. FA IMAGING PROVIDED NURSE WITH TIPS ON HOW TO CLEAR ISSUE AS A WORK AROUND UNTIL UPDATED SOFTWARE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737901 SITE~RITE 8 ULTRASOUND SYSTEM CONSOLE WITH CONNECTOR SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BARD ACCESS SYSTEMS 9770600 N/A 00801741138263

    Patients

    Seq Age Sex Outcome Treatment
    1