BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERVENTIONAL ANGIOGRAPHY SYSTEM

    MDR report key: 11684838 · Received April 19, 2021

    Report

    Report Number
    11684838
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Date of Event
    October 15, 2020
    Report Date
    March 9, 2021
    Manufacturer
    CANON MEDICAL SYSTEMS CORPORATION
    Product Code
    OWB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INTERVENTIONAL RADIOLOGY PATIENT POSITIONED PRONE SLIPPED LATERALLY AND SUDDENLY FELL FROM TABLE TO FLOOR DURING CONCLUSION OF PROCEDURE THOUGH CAREGIVERS NEXT TO TABLE. PATIENT WAS CENTERED AND MATTRESS STAYED IN PLACE. PATIENT NEEDED SERIAL CT SCANS. SMALL SUBARACHNOID HEMORRHAGE. NO SURGERY NEEDED. NO STRAPS THAT ARE ATTACHED TO TABLE FOR USE IN SECURITY PATIENT. NO STRAPS THAT ADHERE TO PAD ON TOP OF TABLE. RECOMMENDATIONS NOT FOUND IN INSTRUCTIONS FOR USE (IFU) OF TABLE. REACHING OUT TO SALES REP TO SEE IF THEY HAVE SOME SUGGESTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582454 INTERVENTIONAL ANGIOGRAPHY SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB CANON MEDICAL SYSTEMS CORPORATION INFX-8000C

    Patients

    Seq Age Sex Outcome Treatment
    1 25550 DA Other