BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)

    MDR report key: 8466114 · Received March 29, 2019

    Report

    Report Number
    2021710-2019-10061
    Event Type
    Injury
    Date Received
    March 29, 2019
    Date of Event
    February 28, 2019
    Report Date
    March 28, 2019
    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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION: VYAIRE MEDICAL TESTED THE SUSPECT DEVICE AND THE VENTILATOR PASSED ALL TESTS PER MANUFACTURERS SPECIFICATIONS. VYAIRE MEDICAL WAS NO ABLE TO DUPLICATE THE CUSTOMER'S REPORTED ISSUE. THE VENTILATOR WAS DUE FOR ROUTINE MAINTENANCE, VYAIRE MEDICAL PERFORMED THE ROUTINE MAINTENANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE NUMBERS ON THE VENTILATOR KEPT FLUCTUATING WHILE IN USE ON A PATIENT INTERMITTENTLY. THE VENTILATOR WAS SWAPPED OUT AND THERE WAS NO PATIENT COMPROMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258549 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) VENTILATOR, HIGH FREQUENCY LSZ VYAIRE MEDICAL 3100 A 10846446003079

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention