BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VYAIRE MEDICAL OY

    MDR report key: 19672015 · Received July 3, 2024

    Report

    Report Number
    3010838917-2024-00204
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    June 7, 2024
    Report Date
    July 3, 2024
    Manufacturer
    VYAIRE OY
    Product Code
    CBL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS ALL INFORMATION REASONABLY KNOWN AS OF 03 JUL 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    SUN MED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT UNITS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 3010838917-2024-00202 FOR THE FIRST REPORT. REFER TO 3010838917-2024-00203 FOR THE SECOND REPORT. IT WAS REPORTED, [IT WAS OBSERVED] LEAKING AND FAILURE OF THE PRODUCT TO REMOVE CARBON DIOXIDE (CO2) FROM THE CIRCUIT. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED ON 20JUN2024 REPORTED, THE NEXT ONE DID THE SAME; I HAD TO TURN THE FLOWS UP TO REMOVE THE CO2. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564776 VYAIRE MEDICAL OY MULTI ABSORBER EF, DISPOSABLE CIRCUITS CBL VYAIRE OY M1173311 L01A-01975

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown