BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAVISTA

    MDR report key: 11318660 · Received February 11, 2021

    Report

    Report Number
    3004553423-2021-00845
    Event Type
    Injury
    Date Received
    February 11, 2021
    Date of Event
    January 13, 2021
    Report Date
    January 13, 2021
    Manufacturer
    IMTMEDICAL AG
    Product Code
    CBK
    UDI-DI
    07640149380026
    PMA / PMN Number
    K163127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H11: AFTER FURTHER REVIEW OF THIS COMPLAINT. VYAIRE MEDICAL FOUND OUT THAT THIS COMPLAINT IS ONLY A DUPLICATE OF THE ORIGINAL REPORT RECEIVED LAST 13-JAN-2021. THEREFORE, THIS IS DEEMED AS A NON QUALITY COMPLAINT TO VYAIRE MEDICAL. PLEASE REFER TO THE ORIGINAL MEDWATCH REPORT WITH REFERENCE NUMBER, (B)(4). VYAIRE REFERENCE NUMBER OF THE ORIGINAL COMPLAINT: (B)(4) UNDER MEDWATCH MANUFACTURER REPORT NUMBER: 3004553423-2021-00827.

    Additional Manufacturer Narrative · 0

    RESULT OF INVESTIGATION: VYAIRE MEDICAL WAS ABLE TO VERIFY THE CUSTOMER'S REPORTED ISSUE. BENCH TESTING REVEALED A DEFECTIVE O2 PRESSURE REGULATOR. MOST LIKELY RESTRICTION OF THE P2 REGULATOR HOLE CAUSED BY INJECTION MOLDING DEBURRS DURING MANUFACTURING. EXACT ROOT CAUSE UNDER INVESTIGATION. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. 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

    IT IS REPORTED TO VYAIRE MEDICAL THAT THE BELLAVISTA 1000 EXPERIENCED VENT GOING INTO BACKUP MODE DURING PATIENT USE. THERE WAS NO INFORMATION REGARDING PATIENT HARM AND INTERVENTION FACILITATED BY THE END USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215674 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK IMTMEDICAL AG BELLAVISTA 1000E 07640149380026

    Patients

    Seq Age Sex Outcome Treatment
    1