BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLAVISTA

    MDR report key: 22646992 · Received July 29, 2025

    Report

    Report Number
    3013421741-2025-01663
    Event Type
    Malfunction
    Date Received
    July 29, 2025
    Date of Event
    July 9, 2025
    Report Date
    July 9, 2025
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    CBK
    UDI-DI
    07640149388879
    PMA / PMN Number
    K183364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE DEVICE LOG FILES WERE PROVIDED TO TECHNICAL SUPPORT FOR EVALUATION. TECH SUPPORT REVIEWED THE LOGS AND FOUND OCCURRENCES OF TF 271 (O2 SUPPLY FAILED - NO O2 DOSING POSSIBLE) AND TF 388 (NO O2 DOSING POSSIBLE) OCCURRING TOGETHER INTERMITTENTLY, DURING WHICH THE O2 SUPPLY PRESSURE READINGS CONFIRMED THAT OXYGEN WAS CONNECTED. THESE FAULT COMBINATIONS ARE INDICATIVE OF AN INSPIRATION BLOCK FAILURE. TECHNICAL SUPPORT RECOMMEND REPLACEMENT OF INSPIRATION BLOCK TO RESOLVE THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE ALARMS WHEN GAS SOURCE IS CONNECTED. ALARM STATES "NO OXYGEN SUPPLY." THE COMPLAINT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160761 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC 301.100.130 NA 07640149388879

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown