BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV 1200 VENTILATOR

    MDR report key: 18321402 · Received December 13, 2023

    Report

    Report Number
    2021710-2023-18520
    Event Type
    Malfunction
    Date Received
    December 13, 2023
    Date of Event
    November 20, 2023
    Report Date
    December 13, 2023
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    CBK
    UDI-DI
    00845873002696
    PMA / PMN Number
    K083688
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: A THIRD PARTY SERVICE TECHNICIAN EVALUATED THE VENTILATOR AND FOUND THAT THE UNIT WAS ALARMING "HIGH PEEP"AND "LOW PEEP" DURING USE. AS A RESOLUTION,THE SOLENOID MANIFOR WAS REPLACED. 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: CORRECTION. D4: MODEL#, G4: PMA/510K. THE SUPPLEMENTAL REPORT HAS CORRECTED THE MODEL# TO 18888-201 AND PMA/510K TO K083688.

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: VYAIRE MEDICAL WAS NOT ABLE TO VERIFY THE CUSTOMER COMPLAINT. THE SUSPECT DEVICE WAS RETURNED FOR INVESTIGATION. VYAIRE RECEIVED SOLENOID MANIFOLD ASSEMBLY PN 18528-001 SN (B)(6). A VISUAL INSPECTION OF ASSEMBLY WAS PERFORMED AND FOUND NO INDICATIONS OF DAMAGE, MISUSE, OR CONTAMINATION. ASSEMBLY WAS LEAK TESTED ACCORDING TO SOLENOID MANIFOLD TEST PROCEDURE 18282-001 LEAKAGE TESTS 7 THROUGH 9 WERE PERFORMED ACCORDING TO PROCEDURE AND WERE FOUND TO BE WITHIN THE = 0.5CMH2O/MIN SPECIFICATION. SOLENOID MANIFOLD WAS THEN INSTALLED ONTO FIXTURE ID LTVSOL13 FOR AUTOMATED TESTING. TEST RESULTS FOUND SOLENOID MANIFOLD PASSING ON ALL COUNTS. PROCEEDED TO INSTALL SOLENOID MANIFOLD INTO A KNOWN GOOD TOP-LEVEL LTV 1200 SYSTEM. LTV UNIT WAS SET ON ADULT DEFAULT SETTINGS AND ALLOWED TO RUN ON ADULT DEFAULT SETTINGS, PEEP WAS SET TO 5CMH2O FOR APPROX. 30 MINS AND OBSERVED NO CIRCUIT RELATED ERRORS, NO HIGH OR LOW PEEP ALARMS PRESENT. THE REPORTED COMPLAINT WAS UNABLE TO BE DUPLICATED. MANIFOLD ASSEMBLY WAS LEAK TESTED ACCORDING TO TEST PROCEDURES, AS WELL AS THROUGH AUTOMATED TESTING AND WAS FOUND TO BE WITHIN SPECIFICATIONS. ASSEMBLY WAS ALSO INSTALLED INTO A KNOWN GOOD LTV SYSTEM AND WAS UNABLE TO OBSERVE ANY PEEP ALARMS DURING OPERATION. MANIFOLD ASSEMBLY WAS FOUND TO BE PERFORMING AS INTENDED. SOLENOID MANIFOLD ASSEMBLY PN 18528-001 SN (B)(6) WILL BE SCRAPPED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL PROBLEM WITH THE LAPTOP 1200 VENTILATOR IN WHICH A DEFECTIVE SOLENOID MANIFOLD IS CAUSING HIGH AND LOW PEEP (POSITIVE END-EXPIRATORY PRESSURE) ALARMS DURING USE. FURTHERMORE, THERE WAS NO PATIENT HARM REPORTED ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261447 LTV 1200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC 18888-201 00845873002696

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown