BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1241945 · Received November 12, 2008

    Report

    Report Number
    1241945
    Event Type
    Malfunction
    Date Received
    November 12, 2008
    Date of Event
    July 27, 2008
    Report Date
    November 12, 2008
    Manufacturer
    OHIO MEDICAL CORPORATION
    Product Code
    JCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    SUCTION UNIT ON HEADWALL FAULTY - PLUER-EVAC CHANGED WITHOUT DIFFERENCE. EITHER ABLE TO GET LARGE AMOUNT BUBBLING IN SUCTION OR NONE AT ALL. FOLLOW UP CHEST X-RAY SHOWED LARGE PNEUMOTHORAX, THEREFORE ASPIRATION AND SUCTION CONTROL CHANGED (NO SUCTION CANISTER USED). ONCE WALL SUCTION WAS CHANGED, PLUER-EVAC WORKED BETTER WITH STEADY BUBBLING. SUCTION UNIT APPEARED TO HAVE MALFUNCTIONED, CAUSING TOO MUCH SUCTION WHICH CAUSED PNUEMOTHORAX (COLLAPSED LUNG). SUCTION UNIT REPAIRED AND RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * REGULATOR, WALL, INTERMITTENT SUCTION JCX OHIO MEDICAL CORPORATION 67051251905 *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DAY