BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDI

    MDR report key: 4705867 · Received February 12, 2015

    Report

    Report Number
    4705867
    Event Type
    Malfunction
    Date Received
    February 12, 2015
    Date of Event
    December 17, 2014
    Report Date
    February 12, 2015
    Manufacturer
    IMAGING DIAGNOSTICS INC.
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON THE OPERATING ROOM PORTABLE CYSTO TABLE, THERE IS A CONCERN WITH THE IDI STIRRUPS. THEY ARE UNABLE TO SECURE A PATIENT'S LEGS, AND THEY FALL OUTWARD TO THE SIDE. IN THIS CASE, USING THE IDI MOBILE CYSTO TABLE, AND POSITIONING PATIENT IN BLACK STIRRUPS, WE NOTICED AFTER THE CASE THE STIRRUPS DID NOT STAY IN THE POSITION THEY WERE PLACED AT THE BEGINNING OF THE CASE. THE PATIENT'S LEGS WERE SECURED, AND THE STIRRUPS WERE LOCKED INTO THE POSITION NEEDED. THERE IS NO DOCUMENTATION OF PATIENT INJURY. ONE MONTH LATER THERE WAS ANOTHER INSTANCE OF THE SAME ISSUE; HOWEVER, WE DO NOT HAVE ANY PATIENT INFORMATION FROM THAT STIRRUP ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104830 IDI TABLE, OPERATING-ROOM, AC-POWERED FQO IMAGING DIAGNOSTICS INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR