BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV 1200 VENTILATOR

    MDR report key: 15353119 · Received September 2, 2022

    Report

    Report Number
    2021710-2022-16565
    Event Type
    Death
    Date Received
    September 2, 2022
    Date of Event
    August 1, 2022
    Report Date
    August 8, 2022
    Manufacturer
    VYAIRE MEDICAL INC.
    Product Code
    CBK
    UDI-DI
    00845873000029
    PMA / PMN Number
    K060647
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS RETURNED AND EVALUATION IS ANTICIPATED BUT NOT YET BEGAN. 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 EVALUTION. A VISUAL INSPECTION OF DEVICE WAS CONDUCTED AND FOUND NO VISIBLE SIGNS OF DAMAGE, DEFECTS, OR CONTAMINATION. THE DEVICE WAS CONNECTED TO AN EXTERNAL POWER SOURCE AND POST AND EVENT TRACE DATA WAS RETRIEVED AND REVIEWED. THIS DEVICE LAST UNDERWENT AUTOMATED TESTING ON (B)(6) 2008, PASSING ON ALL COUNTS. NO FAILURES NOTED. ACCORDING TO EVENT TRACE FINDINGS, THE VENTILATOR WAS FOUND TO BE OPERATING AS EXPECTED. 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 A PATIENT EXPIRED DURING USE ON THE LAP TOP VENTILATOR 1200. THE CUSTOMER REPORTED THERE WAS NO ISSUE WITH NORMAL OPERATION OF THE UNIT NOTED DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2560564 LTV 1200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL INC. LTV 1200 00845873000029

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death