BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OAKWORKS CFPM400 FLUOROSCOPY TABLE

    MDR report key: 3035897 · Received December 20, 2012

    Report

    Report Number
    2529571-2012-00001
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    OAKWORKS, INC.
    Product Code
    IXR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    FLUOROSCOPY TABLE ACTUATOR FAILED CAUSING TABLE TO TILT FORWARD EXCESSIVELY, CAUSING PATIENT TO SLIDE OFF TABLE TOP TO FLOOR, NO INJURY OR INTERVENTION REPORTED. NO OTHER FAILURES OF THIS TYPE IN HISTORY OF PRODUCT CANNOT DETERMINE IF PRODUCT WAS MISUSED.

    Description of Event or Problem · 1

    ACTUATOR FAILED, ALLOWING TABLE TO RAPIDLY TILT FORWARD, PATIENT SLID OFF TABLE TO FLOOR. NO INJURY OR INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OAKWORKS CFPM400 FLUOROSCOPY TABLE FLUOROSCOPY TABLE IXR OAKWORKS, INC. CFPM400

    Patients

    Seq Age Sex Outcome Treatment
    1