BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV 1150 VENTILATOR

    MDR report key: 13546194 · Received February 16, 2022

    Report

    Report Number
    2021710-2022-15586
    Event Type
    Death
    Date Received
    February 16, 2022
    Date of Event
    January 7, 2022
    Report Date
    January 10, 2022
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    UDI-DI
    00845873002726
    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

    (B)(4). VYAIRE MEDICAL HAS RECEIVED THE COMPONENT IN QUESTION, HOWEVER THE EVALUATION HAS NOT YET BEGUN. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56. IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    VYAIRE COMPLAINT NUMBER (B)(4). THE AFFECTED SAMPLE WAS RETURNED FOR EVALUATION, AND VISUAL AND FUNCTIONAL TESTS WERE PERFORMED, AND EVENT TRACE WERE REVIEWED, THIS INVESTIGATION REVEALED THAT THE THE VENTILATOR FUNCTIONED NORMALLY. THE VYAIRE MEDICAL FAILURE ANALYSIS TECHNICIAN WAS UNABLE TO CONFIRM OR DUPLICATE THE REPORTED ISSUE. FOR THE EVENT IN QUESTION UNIT EVENT TRACE INDICATED BOTH, A LOSS OF EXTERNAL POWER AND OPERATION ON THE INTERNAL BATTERY.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THERE WAS AN EVENT ON (B)(6) 2022 WHERE THIS UNIT WAS ON A HOMECARE PATIENT. THE CARETAKER REPORTED THAT A FUSE IN THE HOUSE ""BLEW"" AND ALLEGES THAT THE VENT DID NOT SWITCH OVER TO THE INTERNAL BATTERY. THE POLICE STATE THERE WAS NO MENTION OF THE UNIT ALARMING OR NOT. THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1389278 LTV 1150 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL LTV 1150 00845873002726

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death