BEUDAMED
    FDA Adverse Event Other Summary report: N

    PATIENT BOX, USED WITH THE LIFE PULSE VENTILA

    MDR report key: 1925644 · Received November 5, 2010

    Report

    Report Number
    1719232-2010-00002
    Event Type
    Other
    Date Received
    November 5, 2010
    Date of Event
    January 22, 2010
    Report Date
    November 4, 2010
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    PMA / PMN Number
    P850064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR FAILURE INVESTIGATION FOUND NO MALFUNCTION. UNRELATED TO THE REPORTED SYMPTOM, THE PRESSURE TRANSDUCER AND THE TRANSDUCER MANIFOLD WERE REPLACED AS A PREVENTIVE MEASURE.

    Description of Event or Problem · 1

    A PT CONNECTED TO OUR LIFE PULSE HIGH FREQUENCY VENTILATOR SYSTEM CODED. WHEN THE SUPERVISOR OF RESPIRATORY CARE RESPONDED TO THE CALL, SHE DISCOVERED THE STAFF HAD PULLED APART THE CV CIRCUIT AND THE ENDOTRACHEAL TUBE WAS TOO LOW. SHE STARTED TO BAG THE PT AND THE PT RESPONDED. NO ALARMS WERE SOUNDING AND EVERYTHING SEEMED TO BE WORKING. THEY CHANGED OUT THE PT BOX (USED WITH THE LIFE PULSE HIGH FREQUENCY VENTILATOR) AND RESUMED VENTILATION. THE PT RESPONDED. THE SUPERVISOR OF RESPIRATORY CARE DID NOT BELIEVE ANYTHING WAS WRONG WITH THE PT BOX BUT WANTED IT EVALUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATIENT BOX, USED WITH THE LIFE PULSE VENTILA NONE LSZ BUNNELL, INC. 312 5J0417

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other