BEUDAMED
    FDA Adverse Event Death Summary report: N

    PNEUPAC VENTILATORS PARAPAC PLUS

    MDR report key: 8182027 · Received December 19, 2018

    Report

    Report Number
    3012307300-2018-08889
    Event Type
    Death
    Date Received
    December 19, 2018
    Date of Event
    November 16, 2018
    Report Date
    September 5, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTL
    UDI-DI
    35019315107263
    PMA / PMN Number
    K123957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE VENTILATOR WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE DEVICE FOUND IT TO BE IN GOOD PHYSICAL CONDITION. UNIT THEN UNDERWENT FUNCTIONAL TESTING; CONNECTED TO 50 PSI AIR AND POWERED ON. SETTINGS WERE VARIED, AND DEVICE WAS POWERED ON AND OFF SUCCESSFULLY. DEVICE RAN OVER THE COURSE OF THREE DAYS, SEVEN HOURS EACH DAY. DEVICE FUNCTIONED AS INTENDED THROUGHOUT TESTING PERIOD. THE INPUT MANIFOLD WAS REPLACED AS A PREVENTIVE MEASURE, AND MINOR CALIBRATION WAS REQUIRED. DEVICE PASSED ALL FUNCTIONAL TESTS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED STATING IT WAS DETERMINED BY THE CUSTOMER'S RISK TEAM THAT OTHER FACTORS OTHER THAN THE DEVICE LED TO THE PATIENT'S DEATH.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PNEUPAC VENTILATORS PARAPAC PLUS WAS "INVOLVED IN A PATIENT INCIDENT". IT WAS REPORTED THE PATIENT WAS "ROOM MONITORED" IN THE HOSPITAL AND WAS "NOT BEING VENTILATED". IT WAS ALSO NOTED THE ISSUE WAS NOT RESOLVED AS THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020221 PNEUPAC VENTILATORS PARAPAC PLUS VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) BTL SMITHS MEDICAL ASD, INC. P310NUS 35019315107263

    Patients

    Seq Age Sex Outcome Treatment
    1 Death