BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLID STATE X-RAY IMAGER (FLOAT PANEL/DIGITAL IMAGER)

    MDR report key: 5238605 · Received November 20, 2015

    Report

    Report Number
    5238605
    Event Type
    Malfunction
    Date Received
    November 20, 2015
    Date of Event
    October 20, 2015
    Report Date
    October 30, 2015
    Manufacturer
    FUJIFILM MEDICAL SYSTEM U.S.A., INC.
    Product Code
    MQB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PROPRIETARY CABLE THAT CONNECTS THE FUJI DIGITAL PLATE (MODEL DR-ID 601SE) TO THE FUJI WORKSTATIONS BREAKS EASILY. THIS IS THE FOURTH TIME THE CABLE BROKE DURING NORMAL ROUTINE USE. THERE IS A 7-PIN CONNECTOR THAT HAS A SMALL, BLACK PLASTIC CASE. THE BLACK PLASTIC AROUND THE PINS BREAKS EASILY. MANUFACTURER RESPONSE FOR FUJI DIGITAL RADIOGRAPHY PLATE, DR-ID 601SE (PER SITE REPORTER): REPLACEMENT OF THE CABLE DURING TECHNICAL SERVICE. STATED OTHER FACILITIES ARE ABLE TO USE PRODUCT WITHOUT BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769246 SOLID STATE X-RAY IMAGER (FLOAT PANEL/DIGITAL IMAGER) MQB FUJIFILM MEDICAL SYSTEM U.S.A., INC. DR-ID 601SE

    Patients

    Seq Age Sex Outcome Treatment
    1 OTHER, DIAGNOSTIC X-RAY IMAGING WITH DIGITAL RAD