BEUDAMED
    FDA Adverse Event Death Summary report: N

    PNEUPAC PARAPAC WITH ALARMS

    MDR report key: 1309946 · Received February 10, 2009

    Report

    Report Number
    2182466-2009-00003
    Event Type
    Death
    Date Received
    February 10, 2009
    Date of Event
    January 9, 2009
    Report Date
    January 12, 2009
    Product Code
    BTL
    PMA / PMN Number
    K020899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITHS MEDICAL PM, INC. IMPORTS THE VENTILATOR FROM SMITHS MEDICAL INTERNATIONAL;, LTD. SMITHS MEDICAL PM, INC. KITS A PT CIRCUIT AND REGULATOR AND PACKAGES IT WITH THE VENTILATOR, THEREFORE, SMITHS MEDICAL PM, INC. IS REPORTING AS THE MFR. THE RETURNED QUESTIONNAIRE FROM THE USER FACILITY NOTED THAT THE 'ON/OFF' CONTROL WAS NOTED AS BEING IN THE 'OFF; POSITION. THIS POSITION IS THE 'DEMAND' ONLY POSITION AND WILL PROVIDE VENTILATION TO A SPONTANEOUSLY BREATHING PT, BUT NOT TO A NON BREATHING PATIENT. USERS ARE ADVISED ON BOTH THE USER INFO LABEL FITTED TO THE TOP OF THE VENTILATOR AND IN THE IFU, WHEN SETTING THE VENTILATOR, TO TURN THE MAIN PNEUMATIC SWITCH TO 'ON'. THIS WILL SUPPORT A SPONTANEOUSLY BREATHING PT, BUT ALSO REVERT TO CONTROLLED MANDATORY VENTILATION IN THE EVENT OF THE PT'S BREATHING STOPPING. THE USER FACILITY WAS NOTIFIED OF THIS INFO AND AMENDED THE USER FACILITY QUESTIONNAIRE RESPONSE. THE USER FACILITY IS HAVING THE VENTILATOR EVALUATED BY A THIRD PARTY. THE DEVICE HAS NOT BEEN EVALUATED AT THIS TIME. SMITHS MEDICAL PM, INC. HAS REQUESTED A COPY OF THE DEVICE EVALUATION REPORT WHEN IT BECOMES AVAILABLE. SMITHS MEDICAL PM, INC. HAS ALSO REQUESTED A COPY OF THE USER FACILITY'S MEDWATCH REPORT FOR THIS INCIDENT. ATTACHED: USER FACILITY QUESTIONNAIRE. ATTACHMENT: EMAIL FROM SMITHS MEDICAL INTERNATIONAL, LTD. REGARDING INCIDENT. ATTACHMENT: ADDENDUM TO USER FACILITY QUESTIONNAIRE. ATTACHMENT: IFU PAGES DESCRIBING 'ON/OFF' FUNCTION.

    Description of Event or Problem · 1

    PT WAS ON MRI TABLE, BEING PREPPED FOR MRI AND THE PT WAS BEING VENTILATED WITH PORTABLE MRI VENTILATOR. THE PT AT THIS TIME WAS BREATHING BETWEEN HIGH 30S TO LOW 40S BREATHS/MINUTE. THE 2 NURSES IN THE ROOM NOTED THAT THE PT COUGHED TWICE THEN THE PORTABLE MRI VENTILATOR STOPPED VENTILATING AND SHUT DOWN. PT WAS NOTED AS NOT BREATHING; RT STARTED BAGGING THE PT, THEN REMOVED THE PT FROM THE MRI TABLE TO MRI WAITING AREA. PULSE WAS NOT ABLE TO BE OBTAINED, CODE BLUE CALLED. THE PT WAS BAGGED BY RT DURING THIS TIME UNTIL TAKEN BACK TO ICU. UNABLE TO DETERMINE IF THE RESPIRATORY ARREST WAS RELATED TO THE MRI VENTILATOR. THE PATIENT EXPIRED 3 DAYS LATER AFTER THE PT'S FAMILY DECIDED TO WITHDRAW CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PNEUPAC PARAPAC WITH ALARMS EMERGENCY VENTILATOR BTL 120003V

    Patients

    Seq Age Sex Outcome Treatment
    1 Death