BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV 1200 VENTILATOR

    MDR report key: 15452245 · Received September 19, 2022

    Report

    Report Number
    2021710-2022-16518
    Event Type
    Malfunction
    Date Received
    September 19, 2022
    Date of Event
    July 26, 2022
    Report Date
    July 26, 2022
    Manufacturer
    VYAIRE MEDICAL INC.
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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

    VYAIRE FAILURE ANALYSIS WAS ABLE TO VERIFY THE REPORTED PROBLEM. ISOLATED TO COLLAPSED DOME BUTTON INTERMITTENTLY MAKING CONTACT. THE LTV (LAP TOP VENTILATOR) MEMBRANE ASSY P/N 17513-001 WAS VISUALLY INSPECTED, UUT (UNIT UNDER TEST) FOUND NO SIGNS OF DAMAGE OR MISUSE. PRESSED THE MEMBRANE BUTTONS ON A FLAT SURFACE, SOME BUTTONS WERE FOUND TO HAVE NO TACTILE CLICK/FEEDBACK. MEMBRANE SWITCH WAS CONNECTED TO A KNOWN GOOD LTV SYSTEM AND POWERED ON. PERFORMED VENT CHECK -CONTROL FUNCTION TO CONFIRM MEMBRANE FUNCTIONALITY. FOUND ASSIST/CTRL-SIMV/CPAP BUTTON WOULD INTERMITTENTLY ACTIVATE INVOLUNTARILY. THIS DOME BUTTON WAS FOUND TO COLLAPSED AND VERY SENSITIVE MAKING CONTACT AND THE SELECT, BREATH RATE, VOLUME/PRESSURE, AND SILENCE RESET BUTTONS TO BE COLLAPSED.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: G3, G6, H2, H3, H6 AND H10 RESULT OF INVESTIGATION: VYAIRE FAILURE ANALYSIS WAS ABLE TO DUPLICATE THE REPORTED ISSUE. THE UUT (UNIT UNDER TEST) WAS TESTED AND FAILED DUE TO INTERNAL DAMAGE. UNIT FAILS ALARM TEST DURING BENCH TESTING DUE TO A NON-CONFORMING ALARM SOUNDER PN 21150-001. AS A RESOLUTION, THE ALARM SOUNDER WAS REPLACED AND PROCESS VENTILATOR THRU SERVICE. VISUAL INSPECTION FOUND NO VISIBLE DEFECTS, DAMAGED OR CONTAMINATION. THE UUT WAS INSTALLED INSTALLED TO A KNOWN GOOD VENTILATOR. A SERIES OF ON/OFF CYCLES WERE PERFORMED AND THE UUT WAS FOUND TO BARELY AUDIBLE WHEN ALARMING. WITH THE [?]ALARM OPS' SELECTED THE ALARM VOLUME SET AT 85DB WAS FOUND TO ADJUST NORMALLY BUT, AT A REDUCED VOLUME. UUT FOUND TO HAVE A RESISTANCE VALUE OF 15. TYPICAL VALUE IS LESS THAN 20. THE UUT SUCCESSFULLY UNDER WENT AN X-RAY INSPECTION AT WHICH A DISLODGED DIAPHRAGM CAUSED THE MUFFLED VOLUME ALARM OF THE SOUNDER. 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 LAP TOP VENTILATOR 1200 WHILE ON A PATIENT, THE LEDS AT THE VENT MODE BUTTONS BEGAN TO FLASH (SIMILAR TO WHEN THE VENT MODE IS BEING MANUALLY CHANGED).THE ALARM SOUNDER IS NOT WORKING AS WELL AND NO ALARM SOUNDS OCCURRED AT ALL. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT SINCE THE UNIT DID NOT ACTUALLY CHANGE MODE OR FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2694540 LTV 1200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL INC. LTV 1200

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown