BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV 1150 VENTILATOR

    MDR report key: 17367794 · Received July 20, 2023

    Report

    Report Number
    2021710-2023-17987
    Event Type
    Death
    Date Received
    July 20, 2023
    Date of Event
    June 20, 2023
    Report Date
    July 20, 2023
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    PMA / PMN Number
    K101643
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS RETURNED AND EVALUATION IS ANTICIPATED BUT NOT YET BEGUN. ONCE A FINAL INVESTIGATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: VYAIRE MEDICAL RECEIVED THE DEVICE FOR EVALUATION. TECHNICIAN VISUALLY INSPECTED LAP TOP VENTILATOR UNIT. FOUND NORMAL USE WEAR AND NO OTHER ANOMALIES. CONNECTED AC POWER AND SET UP LAP TOP VENTILATOR UNIT TO PERFORM A POWER UP POST TEST, PASSED AT ALL SEGMENTS. DOWNLOADED AND REVIEWED THE EVENTS TRACE, FOUND NO ABNORMAL ENTRIES INDICATING A FAILURE WITH UNIT. DATE OF INCIDENT WAS REPORTED TO BE ON 20JUN2023. THE ONLY EVENTS FOUND IN THE MONTH OF JUNE WERE ON 12JUN2023/ 29JUN2023. THE EVENTS LOG SHOWS THAT THE UNIT WAS POWERED ON AND IMMEDIATELY TURNED OFF ON BOTH OCCASIONS 12JUN2023/ 29JUN2023. FOUND NO ABNORMAL EVENTS TRACE ENTRIES, LAPTOP VENTILATOR UNIT OPERATED NORMALLY. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT PATIENT EXPIRED ON THE LAP TOP VENTILATOR 1150.NO OTHER INFORMATION IS GIVEN REGARDING THE REPORTED EVENT. THERE WAS NO ALLEGATION OF MALFUNCTION ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632452 LTV 1150 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL LTV 1150

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death