BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OAKWORKS MEDICAL CFPM 400 IMAGING TABLE

    MDR report key: 9842387 · Received March 17, 2020

    Report

    Report Number
    2529571-2020-00001
    Event Type
    Malfunction
    Date Received
    March 17, 2020
    Date of Event
    August 10, 2015
    Report Date
    March 2, 2020
    Manufacturer
    OAKWORKS, INC.
    Product Code
    IXR
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL PROCESS AUDIT FINDING CREATED A TASK FOR PAR #5 (PREVENTATIVE ACTION RECOMMENDATION) FROM CAPA (B)(4) TO REVIEW THE COMPLAINT DATA AND RETROSPECTIVELY REPORT ANY PREVIOUSLY UNREPORTED COMPLAINTS ASSOCIATED WITH FIELD ACTION RECALL (B)(4). FOUR COMPLAINTS WERE FOUND DURING THE REVIEW THAT MEET THE CRITERIA WHICH ARE BEING REPORTED.

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE FOOT CONTROL WAS ACCIDENTALLY PUSHED UNDER THE TABLE AND ONE OF THE BUTTONS WEDGED UNDER THE EDGE OF THE TABLE AND TABLE STARTED TO MOVE. THEY WERE ABLE TO FIGURE OUT WHAT WAS HAPPENING AND PULLED THE FOOT CONTROL OUT FROM UNDER THE EDGE OF THE TABLE. NO PATIENT HARM OR ADVERSE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309177 OAKWORKS MEDICAL CFPM 400 IMAGING TABLE CFPM 400 IMAGING TABLE IXR OAKWORKS, INC. CFPM400 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1