BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV 1150 VENTILATOR

    MDR report key: 12440749 · Received September 8, 2021

    Report

    Report Number
    2021710-2021-14493
    Event Type
    Malfunction
    Date Received
    September 8, 2021
    Date of Event
    August 11, 2021
    Report Date
    August 11, 2021
    Manufacturer
    VYAIRE MEDICAL INC.
    Product Code
    CBK
    UDI-DI
    00845873002726
    PMA / PMN Number
    K060647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION: VYAIRE RECEIVED THE DEVICE FOR EVALUATION. THE FOLLOWING TESTS WERE PERFORMED TO VERIFY THE PERFORMANCE OF THE UNIT UNDER TEST: THE UNIT UNDER TEST WAS DISASSEMBLED AND PHOTOGRAPHS WERE TAKEN DURING THIS PROCESS. WITH THE BOOTS REMOVED IT WAS OBSERVED THAT THERE WAS SOME LIQUID CONTAMINATION PRESENT ON THE LOWER HALF OF THE UNIT UNDER TEST. THE INTERNAL BATTERY WAS REMOVED AND THERE WAS NO VISIBLE DAMAGE FOUND. THE BATTERY VOLTAGE WAS FOUND TO BE 12.08 7VDC. THE UNIT UNDER TEST REAR COVER WAS REMOVED AND INITIAL INSPECTION FOUND LOOSE HARDWARE ADJACENT TO THE TURBINE MANIFOLD. FURTHER INSPECTION FOUND THE MOTOR PRINTED CIRCUIT BOARD ASSEMBLY TO BE MISSING ALL 4 MOUNTING SCREWS AND THE FAN ADDITIONALLY THE MAIN BOARD PRINTED CIRCUIT BOARD ASSEMBLY MOUNTING SCREW ADJACENT TO THE FAN, WAS FOUND TO BE LOOSENED. THE FAN WAS OBSERVED TO BE PARTIALLY MELTED. WITH THE FAN DISCONNECTED FROM THE POWER PRINTED CIRCUIT BOARD ASSEMBLY THE UNIT UNDER TEST WAS POWERED ON IN VENT CHECK MODE AND A POST AND EVENT TRACE WERE PRODUCED, REPORTS ATTACHED. A VENT CHECK DISPLAY TEST WAS PERFORMED WHICH DISCLOSED MANY FAILED LIGHT EMITTING DIODE SEGMENTS. FURTHER INVESTIGATION FOUND DAMAGED COMPONENTS ON THE MAIN PRINTED CIRCUIT BOARD ASSEMBLY P/N 18233-001 REV.B AND THE POWER PRINTED CIRCUIT BOARD ASSEMBLY P/N 27675-001 REV.B. THE POWER PRINTED CIRCUIT BOARD ASSEMBLY SHOWED EVIDENCE OF ONE OF THE LOOSE FAN NUTS ELECTRICALLY SHORTING COMPONENT R186 TO +VDC (13.5 VDC), RESULTING IN DAMAGE TO THE FAN AND R186. PRIOR TO KITTING THE UNIT UNDER TEST UNDERWENT AUTOMATED TESTING AND WAS FINAL TESTED ON APRIL 21, 2009 AND PASSED ON ALL COUNTS. (B)(6) RECORDS SHOW THE UNIT UNDER TEST UNDERWENT SCHEDULED PM SERVICES EVERY 2 YEARS WITH THE LAST SERVICE ON SEPTEMBER 27, 2019. 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 · 1

    THE CUSTOMER REPORTED DEVICE HAS SMOKE COMING OUT OF IT AND A FLAME WAS VISIBLE THROUGH THE FAN PORT ON THE SIDE OF THE VENT WITH AN ACCOMPANYING BURNT PLASTIC ODOR DURING PATIENT USE ON THE LAP TOP VENTILATOR 1150. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT. 6. TESTS/LAB DATA, INCLUDING DATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337500 LTV 1150 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL INC. LTV 1150 00845873002726

    Patients

    Seq Age Sex Outcome Treatment
    1