BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OAKWORKS MEDICAL CFPM 300 IMAGING TABLE

    MDR report key: 6660012 · Received June 22, 2017

    Report

    Report Number
    2529571-2017-00005
    Event Type
    Malfunction
    Date Received
    June 22, 2017
    Date of Event
    March 31, 2015
    Report Date
    June 6, 2017
    Manufacturer
    OAKWORKS, INC.,
    Product Code
    IXR
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RECURRING ISSUE.

    Description of Event or Problem · 1

    (B)(6) FROM PERFORMANCE IMAGING TECHNOLOGIES CALLED IN AND STATED THAT THEY KICK THE FOOT PEDAL WHILE MOVING AROUND THE TABLE AND IN SOME INSTANCES, THE FOOT PEDAL GETS KICKED UNDER THE BASE OF THE TABLE. THE FOOT PEDAL WILL GET LODGED UNDER THE BASE AND THE BUTTON ENGAGES. THIS HAS OCCURRED WITH PATIENTS ON THE TABLE. THE LAST TIME THIS HAPPENED, THEY WERE GETTING READY TO PERFORM A LUMBAR INJECTION WHEN THE FOOT PEDAL WAS KICKED UNDER THE BASE. THIS ENGAGED THE LATERAL ROLL MOVEMENT AND THE TABLE STARTED TO ROLL. THEY WERE ABLE TO STOP IT IN TIME AND THERE WAS NO HARM TO THE PATIENT. WHEN ASKED IF THE PATIENT WAS STRAPPED DOWN USING THE PATIENT SAFETY STRAP THAT COMES WITH THE TABLE, THE CUSTOMER SAID NO, THEY DO NOT USE THE STRAPS TYPICALLY DUE TO THE LOCATION OF THE INJECTIONS WITHIN THE SPINAL COLUMN. (B)(6) WAS ADVISED TO UNPLUG THE FOOT PEDAL AND TO DISCONTINUE THE USE OF IT. THEY CAN USE THE HAND CONTROL TO OPERATE THE TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442015 OAKWORKS MEDICAL CFPM 300 IMAGING TABLE IMAGING TABLE IXR OAKWORKS, INC., CFPM 300

    Patients

    Seq Age Sex Outcome Treatment
    1