BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV 1200 VENTILATOR

    MDR report key: 18526763 · Received January 17, 2024

    Report

    Report Number
    2021710-2024-18670
    Event Type
    Malfunction
    Date Received
    January 17, 2024
    Date of Event
    December 20, 2023
    Report Date
    January 17, 2024
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    CBK
    UDI-DI
    00845873000364
    PMA / PMN Number
    K060647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4) 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.

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: VYAIRE MEDICAL WAS ABLE TO CONFIRM AND DUPLICATE THE ISSUE AND ISOLATED TO FAILED IC UNIVERSAL VOLTAGE MONITOR SO-8 P/N 10494 (U47), VOLTAGE SUPPLY +15V IS BEING SHORTED TO GROUND. ASSY, POWER PCB P/N 27675-001 S/N (B)(6) HAS BEEN REMOVED AND DISPOSED OF. MOVE LTV 1200 SERVICE REPAIR P/N 18888-001-99 S/N (B)(6) TO FACTORY SERVICE TO HAVE A NEW ASSY, POWER PCB INSTALLED, THEN HAVE ASSEMBLY PROCESSED. 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 THE LTV 1200 WOULD NOT POWER BACK ON AFTER BEING TURNED OFF. THE VENT'S BATTERY WAS CHARGED, AND THE ONLY THING THAT LIT UP WAS THE VENT'S INOP ALARM. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395651 LTV 1200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC LTV 1200 SERVICE REPAIR 00845873000364

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown