BEUDAMED
    FDA Adverse Event Death Summary report: N

    PNEUPAC PATIENT CIRCUIT

    MDR report key: 833364 · Received March 30, 2007

    Report

    Report Number
    MW1042357
    Event Type
    Death
    Date Received
    March 30, 2007
    Date of Event
    March 12, 2007
    Report Date
    March 29, 2007
    Manufacturer
    SMITH'S MEDICAL PM
    Product Code
    BZO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    AN HME/ELECTROSTATIC FILTER W/PORT -EVALUEMED- WAS ATTACHED TO A SMITH'S MEDICAL PNEUPAC PATIENT CIRCUIT FOR VENTILATION OF A PATIENT ON THE PNEUPAC MRI TRANSPORT VENTILATOR. AN INCORRECT CONFIGURATION OF THE PNEUPAC PATIENT CIRCUIT AND HME FILTER LED TO A FAILURE TO VENTILATE THE PATIENT. ATTEMPTS TO MANUALLY BAG-VALVE RESUSCITATE WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PNEUPAC PATIENT CIRCUIT PATIENT CIRCUIT BZO SMITH'S MEDICAL PM * *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death PNEUPAC PARAPAC TRANSPORT VENTILATOR-SENDING TO| HME FILTER-NOT AVAILABLE| SMITH'S MEDICAL