BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GC85A

    MDR report key: 12675142 · Received October 21, 2021

    Report

    Report Number
    3004938766-2021-00014
    Event Type
    Injury
    Date Received
    October 21, 2021
    Date of Event
    September 7, 2021
    Report Date
    October 21, 2021
    Product Code
    IZL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INCIDENT WAS REVIEWED BY OUR FIELD SERVICE REPRESENTATIVE ON 09/12/2021 AND IT WAS NOTED THAT THE DEVICE STAND APPLIED PRESSURE TO THE PATIENT'S FOOT, HOWEVER, NO INJURY RESULTED AND THEREFORE, NO INITIAL MDR WAS SENT BY NEUROLOGICA. AT THE TIME OF THE EVENT, THE FIELD SERVICE TECHNICIAN DETERMINED ALL THE COMPONENTS WERE FUNCTIONING CORRECTLY AND THE INCIDENT WAS A USER-INDUCED ISSUE. THE USER HAD KEPT THE TRACKING KEY ON, WHICH RESULTED IN THE UNINTENDED COMPONENT MOVEMENT. THE SITE TECHNICIAN WAS RE-EDUCATED ON THE SYSTEM'S FUNCTIONALITY AND IT WAS COMMUNICATED THAT ALL COMPONENTS SHOULD BE MOVED WHEN THE PATIENT IS NOT PRESENT, OR THE COMPONENTS HAVE BEEN MOVED TO AN AREA NOT AFFECTED BY SYSTEM MOVEMENT. THE ABOVE NARRATIVE ADDS CONTEXT TO THE HOSPITAL SUBMITTED MDR (B)(4). FUTURE SERVICE CALLS WILL BE MONITORED FOR SIMILAR INCIDENTS.

    Description of Event or Problem · 0

    A CUSTOMER MEDICAL DEVICE REPORT (MDR) WAS RECEIVED BY NEUROLOGICA ON OCTOBER 11, 2021. THE MDR STATED WHILE THE SITE TECHNICIAN WAS ATTEMPTING TO COMPLETE A PROCEDURE, THE WALL STAND MOVED ABRUPTLY TO THE FLOOR AND PINNED THE PATIENT'S FOOT, RESULTING IN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1572252 GC85A DIGITAL DIAGNOSTIC X-RAY SYSTEM IZL GC85

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other