BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLAVISTA

    MDR report key: 11344112 · Received February 18, 2021

    Report

    Report Number
    3004553423-2021-00851
    Event Type
    Malfunction
    Date Received
    February 18, 2021
    Date of Event
    January 21, 2021
    Report Date
    January 21, 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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: VYAIRE MEDICAL DETERMINED ROOT CAUSE WAS DUE TO THE DEFECTIVE O2 PRESSURE REGULATOR. MOST LIKELY RESTRICTION OF THE P2 REGULATOR HOLE CAUSED BY INJECTION MOLDING DEBURRS DURING MANUFACTURING. THIS COMPLAINT WILL BE INCLUDED WITH ON-GOING TRENDING ANALYSIS. SCAR SC-CH-20-002 HAS BEEN INITIATED. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE LOG FILE RECEIVED FROM THE CUSTOMER CONFIRMED THAT THE DEVICE HAD THE ALARMS 151, 271 AND 388. NO ROOT CAUSE HAS BEEN DETERMINED AT THIS TIME SINCE THE INVESTIGATION IS STILL ONGOING. 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 BELLAVISTA 1000 HAD NO FLOW WHEN THE OXYGEN DROPPED. THE MACHINE JUST KEPT ALARMING 151 (O2 CONCENTRATION LOW), 271 (O2 SUPPLY FAIL - NO O2 DOSING POSSIBLE) AND 388 (NO O2 DOSING POSSIBLE) AND THE FI02 (FRACTION OF INSPIRED OXYGEN) DROPPED TO 21% JUST FOR ABOUT 3 SECONDS. IT HAPPENED DURING PATIENT USE AND WAS TRANSFERRED TO A BACKUP VENTILATOR. 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
    242729 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK IMTMEDICAL AG BELLAVISTA 1000 07640149380019

    Patients

    Seq Age Sex Outcome Treatment
    1