BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLAVISTA

    MDR report key: 11646023 · Received April 9, 2021

    Report

    Report Number
    3004553423-2021-00937
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 15, 2021
    Report Date
    March 15, 2021
    Manufacturer
    IMTMEDICAL AG
    Product Code
    CBK
    UDI-DI
    07640149380019
    PMA / PMN Number
    K163127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RESULT OF INVESTIGATION: VYAIRE WAS NOT ABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. ACCORDING TO TECHNICAL SUPPORT, CFB LOGGING IS VISIBLE FROM (DEVICE TIME) 12/12/2020 16:59:23 TILL 12/12/2020 17:20:32. ITS VISIBLE AS PER THE LOG ENTRY "VENT STATE-"0 (THIS IS NORMAL, AS NO VENTILATION WAS RUNNING AT THAT TIME), USER FORCE SHUTDOWN THE UNIT AT 12/12/2020 17:20:32 . NURSE CALL IS ACTIVE, RED ALARM LIGHTS WERE ON AND THE BUZZER IS ACTIVE. THE UNIT START TO WORK NORMALLY AFTER THE NEXT RESTART AT 14/12/2020 11:07:01. AS WE HAVE EVIDENCE THAT THE CFB WAS NOT AFFECTED, VENTILATION WOULD HAVE CONTINUED WITH THE LAST SETTINGS. REPAIRS COMPLETED AND UNIT WORKING AS INTENDED. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. HOWEVER, PICTURE OF THE SCREEN LOG FILES HAS BEEN SENT BUT LOOKING AT THE FILES INITIALLY IT DIDN'T REVEAL ANY ISSUES. IT SHOWED THAT CFB LOGS WERE ACTIVE WHEN THEY FURTHER INVESTIGATE THE LOG FILES. TECHNICAL TEAM SUGGESTED TO REPLACED THE MAIN ELECTRONICS DUE TO ACTIVE CFB LOG ON FOR OVER 20 MINS. 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 SCREEN WENT COMPLETELY BLACK AND ALARMED LED'S WERE BLUE. THERE WAS NO PRESENT AUDIBLE ALARM AND THE UNIT WAS IMPOSSIBLE TO POWER DOWN. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542328 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK IMTMEDICAL AG BELLAVISTA 1000 07640149380019

    Patients

    Seq Age Sex Outcome Treatment
    1