BEUDAMED
    FDA Adverse Event Death Summary report: N

    3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)

    MDR report key: 9950307 · Received April 10, 2020

    Report

    Report Number
    2021710-2020-11712
    Event Type
    Death
    Date Received
    April 10, 2020
    Date of Event
    December 23, 2019
    Report Date
    March 24, 2020
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    LSZ
    UDI-DI
    10846446003079
    PMA / PMN Number
    P890057
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VYAIRE MEDICAL COMPLAINT NUMBER: (B)(4). ANY ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER WILL BE INCLUDED IN A FOLLOW UP REPORT. AT THIS TIME, VYAIRE HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VYAIRE MEDICAL THAT ON (B)(6) 2019 THE 3100 A VENTILATOR STOPPED WORKING WHILE CONNECTED TO A PATIENT. THE CUSTOMER UNDERSTANDS THAT THE VENTILATOR BECAME UNPLUGGED SOMEHOW, WHICH RESULTED IN SIGNIFICANT BRAIN DAMAGE TO THE PATIENT. THE PATIENT PASSED AWAY FROM HER INJURIES ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414330 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) VENTILATOR, HIGH FREQUENCY LSZ VYAIRE MEDICAL 3100 A 10846446003079

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Death