BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV 1200 VENTILATOR

    MDR report key: 14382135 · Received May 12, 2022

    Report

    Report Number
    2021710-2022-16028
    Event Type
    Death
    Date Received
    May 12, 2022
    Date of Event
    April 13, 2022
    Report Date
    April 14, 2022
    Manufacturer
    VYAIRE MEDICAL INC.
    Product Code
    CBK
    UDI-DI
    00845873000364
    PMA / PMN Number
    K060647
    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 BEGUN. ONCE A FINAL INVESTIGATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    "RESULTS OF INVESTIGATION: VYAIRE MEDICAL RECEIVED THE DEVICE FOR EVENT TRACE DUE TO DEATH OF A PATIENT. VISUAL INSPECTION OF THE UNIT UNDER TEST (UUT) FOUND NO VISIBLE DEFECTS, DAMAGE, OR CONTAMINATION. THE UUT WAS THEN CONNECTED TO EXTERNAL POWER AND THE POST AND EVENT TRACE WERE PRODUCED AND REVIEWED. THE UUT UNDERWENT A VENT CHECK AND WAS FOUND TO PASS ON ALL COUNTS. A CHECK OF VENT USAGE FOUND THE VENTILATOR HAS 31142.4 HOURS OF OPERATION. THE UUT WAS LEFT CONNECTED TO EXTERNAL POWER FOR A PERIOD OF 10 MINUTES AND IT WAS OBSERVED THAT THE CHARGE STATUS LED DID NOT SWITCH FROM RED TO (FLASHING) AMBER. THE SOLID RED CHARGE STATUS LED IS AN INDICATION OF A FAILED INTERNAL BATTERY. A REVIEW OF THE VENTILATOR PREVENTIVE MAINTENANCE RECORD FOUND THAT AT THE TIME OF THE PATIENT EVENT, THE VENTILATOR WAS 6K HOURS OVERDUE FOR A 10K PM (DUE 5/8/2022 OR 25,686HRS). AS PER THE ENTIRE EVENT TRACE, THERE IS NO FAILURE TO REPORT. THE EVENT TRACE REVIEW FOUND THE VENTILATOR TO HAVE OPERATED TO EXPECTATIONS. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    H11-CORRECTED B5-THE CUSTOMER REPORTED ISSUE WITH LAP TOP VENTILATOR 1200 WHERE UNIT COMING IN FOR EVENT TRACE DOWNLOAD DUE TO DEATH OF A PATIENT. CUSTOMER INDICATED THAT THERE WAS NO INFORMATION REGARDING THE LAST VENT SETTINGS OR ANY OTHER DETAILS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED ISSUE WITH LAP TOP VENTILATOR 1150 WHERE UNIT COMING IN FOR EVENT TRACE DOWNLOAD DUE TO DEATH OF A PATIENT. CUSTOMER INDICATED THAT THERE WAS NO INFORMATION REGARDING THE LAST VENT SETTINGS OR ANY OTHER DETAILS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED ISSUE WITH LAP TOP VENTILATOR 1200 WHERE UNIT COMING IN FOR EVENT TRACE DOWNLOAD DUE TO DEATH OF A PATIENT. CUSTOMER INDICATED THAT THERE WAS NO INFORMATION REGARDING THE LAST VENT SETTINGS OR ANY OTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364926 LTV 1200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL INC. LTV 1200 00845873000364

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death