BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OAKWORKS MEDICAL CFPM 400 IMAGING TABLE

    MDR report key: 9842822 · Received March 17, 2020

    Report

    Report Number
    2529571-2020-00003
    Event Type
    Malfunction
    Date Received
    March 17, 2020
    Date of Event
    July 24, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    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 CALLED; THEY RECEIVED THE ADVISORY NOTICE REGARDING THE FOOT CONTROL FIELD ACTION. THE CUSTOMER WOULD LIKE A NEW FOOT CONTROL ALONG WITH THE RETROFIT KIT OF THE FIELD ACTION. THEIR FOOT CONTROL HAS ALREADY GOTTEN LODGED UNDER TABLE AND WAS CRACKED, SO THEY NEED A NEW FOOT CONTROL TOO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305226 OAKWORKS MEDICAL CFPM 400 IMAGING TABLE IMAGING TABLE IXR OAKWORKS INC. CFPM 400 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1