BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAVISTA

    MDR report key: 21447743 · Received February 24, 2025

    Report

    Report Number
    3013421741-2025-00615
    Event Type
    Injury
    Date Received
    February 24, 2025
    Date of Event
    February 3, 2025
    Report Date
    February 24, 2025
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    PMA / PMN Number
    K183364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION UPDATE: THE DEVICE LOGS AND TRENDING DATA WERE PROVIDED TO TECH SERVICE FOR FURTHER REVIEW. UPON ANALYSIS, TECH SERVICE CONFIRMED THAT DURING BOTH PERIODS, THE SAME ALARMS (105, 104, 260, AND 196) WERE TRIGGERED. TRENDING DATA SHOWED: ON (B)(6) 2024: ABNORMAL WAVEFORMS BEGAN AT 5:07 AM AND WERE RESOLVED BY 5:09 AM, WITH NORMAL WAVEFORMS RESUMING AT 5:11 AM. THE DEVICE LOGS ALSO INDICATE AN OCCLUSION ALARM AND AN IMPROPERLY CONNECTED PROX FLOW SENSOR. ON (B)(6) 2025: ABNORMAL WAVEFORMS WERE OBSERVED FROM 3:08 PM TO 3:23 PM, ALONG WITH FREQUENT OCCLUSION ALARMS IN THE DEVICE LOGS. THESE FINDINGS SUGGEST A POTENTIAL CIRCUIT ISSUE OR A PATIENT-INDUCED EVENT.

    Additional Manufacturer Narrative · 0

    IDENTIFICATION #: (B)(4). D4: UNIQUE IDENTIFIER (UDI) # UNABLE TO DETERMINE ENTIRE UDI# AS INFORMATION WAS NOT PROVIDED. 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 · 0

    ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE CUSTOMER SENT LOG FILES FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENT'S RATE INCREASED RAPIDLY WHILE ON PATIENT TWICE. ANALYZED LOGS AND FOUND THAT DURING BOTH PERIODS A FLURRY OF ALARMS POPPED UP, 105, 104, 260, 196 WHICH MAY INDICATE AN ISSUE WITH THE CIRCUIT OR MAY BE PATIENT INDUCED. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526721 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL 301.100.130

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown