BEUDAMED
    FDA Adverse Event Death Summary report: N

    PNEUPAC PARAPAC WITHOUT ALARMS

    MDR report key: 1356286 · Received April 3, 2009

    Report

    Report Number
    2182466-2009-00006
    Event Type
    Death
    Date Received
    April 3, 2009
    Date of Event
    March 5, 2009
    Report Date
    March 6, 2009
    Manufacturer
    SMITHS MEDICAL PM, INC.
    Product Code
    BTL
    PMA / PMN Number
    K960515
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 PATIENT CIRCUIT AND REGULATOR AND PACKAGES IT WITH THE VENTILATOR, THEREFORE, SMITHS MEDICAL PM, INC. IS REPORTING AS THE MANUFACTURER. AFTER THE INCIDENT, A FUNCTIONAL CHECK OF THE UNIT WAS PERFORMED BY THE BIOMEDICAL DEPARTMENT AT THE USER FACILITY. THE DEVICE PASSED FUNCTIONAL TESTING AND NO MALFUNCTIONS WERE FOUND. THE EVALUATION RESULTS HAVE BEEN OBTAINED AND HAVE BEEN ATTACHED. THE VENTILATOR HAS NOT BEEN RETURNED TO SMITHS MEDICAL PM, INC. TECHNICAL SERVICE DEPARTMENT FOR EVALUATION. THE VENTILATOR IS CURRENTLY BEING HELD BY THE CORONER. SMITHS MEDICAL PM, INC. HAS REQUESTED THAT THE USER FACILITY RETURN THE VENTILATOR TO THE SMITHS MEDICAL PM, INC. TECHNICAL SERVICE DEPARTMENT FOR EVALUATION ONCE THE VENTILATOR HAS BEEN RELEASED BY THE CORONER. ATTACHMENT 2: EVALUATION RESULTS FROM USER FACILITY.

    Description of Event or Problem · 1

    THE PATIENT WAS INTUBATED IN THE FIELD AND TRANSPORTED TO THE EMERGENCY DEPARTMENT. WHILE IN THE EMERGENCY DEPARTMENT, SHE WAS PLACED ON THE HOSPITAL VENT WHERE SHE WAS SEDATED BUT IN NO RESPIRATORY DISTRESS. SHE WAS MOVED FROM ER TO ICU AFTER 0100 USING THE PARAPAC VENTILATOR WITH A PORTABLE OXYGEN TANK WITH A PRESSURE OF 1500PSI PLACED AT THE FOOT OF THE BED. THE PATIENT CIRCUIT WAS USED APPROPRIATELY AS ILLUSTRATED ON THE SAFETY INSTRUCTIONS INCLUDED WITH THE BREATHING CIRCUIT. THE CIRCUIT WAS NOT ALTERED FROM ITS ORIGINAL PACKAGE OTHER THAN ADDING A HUDSON RESPIRATORY FILTER ON THE PROXIMAL END CONNECTING TO THE VENTILATOR LEADING TO THE PATIENT. AN IN-LINE SUCTION CATHETER WAS ATTACHED AT THE PATIENT "Y" WITH AN HME FILTER CONNECTED DISTAL TO THAT. UPON ENTERING THE ICU ROOM, THE PATIENT'S CONDITION DETERIORATED AND NEEDED IMMEDIATE RESUSCITATION AFTER THE PATIENT WAS MOVED FROM THE GURNEY TO THE HOSPITAL BED. THE PARAPAC VENTILATOR WAS TAKEN OFF AND MANUAL VENTILATION PROCEEDED UNTIL THE PATIENT WAS REVIVED AND CONNECTED TO THE HOSPITAL VENTILATOR. THE PATIENT'S NORMAL BRAIN ACTIVITY CEASED AND THE PATIENT DIED SEVERAL DAYS LATER. ATTACHMENT 1: COMPLETED USER QUESTIONNAIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PNEUPAC PARAPAC WITHOUT ALARMS EMERGENCY VENTILATOR BTL SMITHS MEDICAL PM, INC. P20D

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death