BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OAKWORKS MEDICAL CFPM 400 IMAGING TABLE

    MDR report key: 9843260 · Received March 17, 2020

    Report

    Report Number
    2529571-2020-00004
    Event Type
    Malfunction
    Date Received
    March 17, 2020
    Date of Event
    October 26, 2017
    Report Date
    March 2, 2020
    Manufacturer
    OAKWORKS INC.
    Product Code
    IXR
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 #Z-0703-2018. FOUR COMPLAINTS WERE FOUND DURING THE REVIEW THAT MEET THE CRITERIA WHICH ARE BEING REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THEY HAVE A CFM 400 C-ARM TABLE THAT HAS BEEN HAVING AN ISSUE WHERE IT WILL CONTINUE TO GO UP EVEN WHEN NO ONE IS PUSHING THE UP BUTTON, AND USUALLY WON'T STOP UNTIL IT REACHES MAXIMUM HEIGHT. THE ONLY WAY THEY HAVE BEEN ABLE TO STOP IT IS TO USE THE EMERGENCY STOP BUTTON. A REVIEW OF THE FOOT CONTROL PHOTO INDICATES THE CUT WAS ON AN OUTSIDE BUTTON. THIS IMPLIES THE FOOT CONTROL WAS DAMAGED BY CONTACT WITH THE COLUMN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306870 OAKWORKS MEDICAL CFPM 400 IMAGING TABLE IMAGING TABLE IXR OAKWORKS INC. CFPM 400 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1