BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAVISTA

    MDR report key: 11467532 · Received March 11, 2021

    Report

    Report Number
    3004553423-2021-00909
    Event Type
    Injury
    Date Received
    March 11, 2021
    Date of Event
    January 21, 2021
    Report Date
    February 15, 2021
    Manufacturer
    IMTMEDICAL AG
    Product Code
    CBK
    UDI-DI
    07640149380019
    PMA / PMN Number
    K163127
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RESULT OF INVESTIGATION: IT WAS DETERMINED THAT THE ROOT CAUSE OF THE ISSUE WAS THE EXPIRED O2 (OXYGEN) SENSOR AND THERE WAS NO HISTORY OF THE O2 (OXYGEN) CELL REPLACEMENT. S/N OF CELL IS: (B)(6), MANUFACTURE DATE: 180406, EXPIRATION DATE: 191006. O2 (OXYGEN) CONCENTRATION ALARMS TRIGGERED DUE TO DEPLETED O2 (OXYGEN) SENSOR (END OF LIFE).

    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

    THE CUSTOMER REPORTED THAT THE FLOW RATE OF BELLAVISTA 1000 WAS DOUBLED AND HAS AN ALARM 224 (FIO2 MISMATCH) DURING PATIENT USE. THE DEVICE WAS REPLACED WITH ANOTHER VENTILATOR (BV-1000) BUT SAME ISSUE OCCURRED. THE ISSUE DID NOT SHOW UP WITH ANOTHER BV-1000 WHEN THEY REPLACE IT AGAIN. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357791 BELLAVISTA VENTILATOR, CONTINOUS, FACILITY USE CBK IMTMEDICAL AG BELLAVISTA 1000 07640149380019

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention