BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)

    MDR report key: 9461647 · Received December 12, 2019

    Report

    Report Number
    2021710-2019-11147
    Event Type
    Malfunction
    Date Received
    December 12, 2019
    Date of Event
    November 14, 2019
    Report Date
    February 24, 2021
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE COMPLAINT #: (B)(4). RESULTS OF INVESTIGATION: A VYAIRE MEDICAL FIELD SERVICE REPRESENTATIVE (FSR) EVALUATED THE SUSPECT DEVICE ONSITE. THE FSR CALIBRATED THE PR2 AND PR6 REGULATORS AS WELL AS THE PRINTED CIRCUIT BOARD (PCB). THE OPERATION OF THE DEVICE WAS CONFIRMED. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    VYAIRE MEDICAL COMPLAINT NUMBER: (B)(4). AT THIS TIME, VYAIRE MEDICAL HAS NOT RECEIVED THE SUSPECT DEVICE FOR EVALUATION. ONCE EVALUATED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENTILATOR IS NOT PROVIDED THE EXPECTED AMPLITUDE. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1252837 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) VENTILATOR, HIGH FREQUENCY LSZ VYAIRE MEDICAL 3100 A

    Patients

    Seq Age Sex Outcome Treatment
    1