BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLAVISTA

    MDR report key: 8789036 · Received July 15, 2019

    Report

    Report Number
    3004553423-2019-00286
    Event Type
    Malfunction
    Date Received
    July 15, 2019
    Date of Event
    June 19, 2019
    Report Date
    June 19, 2019
    Manufacturer
    IMTMEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K163127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: RESULTS OF INVESTIGATION: TECHNICAL SUPPORT ANALYZED THE LOG FILES RECEIVED. IT WAS VISIBLE THAT THE BLOWER TEMPERATURE ALARMS WERE TRIGGERED MULTIPLE TIMES. AFTER FURTHER EVALUATION, THE ROOT CAUSE WAS TRACED TO USER FAULT. THE BLOWER OVERHEATED DUE TO LACK OF MAINTENANCE (FILTER EXCHANGE). ADDITIONALLY, THE END USER DISREGARDED THE BLOWER TEMPERATURE ALARMS ON NUMEROUS OCCASIONS WHICH EVENTUALLY CAUSED DAMAGE TO THE BLOWER UNIT.

    Additional Manufacturer Narrative · 1

    VYAIRE FILE IDENTIFICATION NO. (B)(4). ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT. CUSTOMER SENT LOGS TO TECHNICAL SUPPORT. LOGS SHOWS THAT HIGH TEMPERATURE ALARMS WERE ACTIVE THEN THE BLOWER STOPS WORKING. TECHNICAL SUPPORT REQUESTED CUSTOMER TO PERFORM SOFTWARE UPDATE AND BLOWER TEST. BLOWER TEST RESULT DOES NOT REVEAL IF THE BLOWER CAUSED THE ISSUE. TECHNICAL SUPPORT ASKED CUSTOMER IF HE HAS A WORKING BLOWER UNIT AVAILABLE TO CHECK IF A NEW BLOWER WILL SOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED "INSPIRATION VALVE OR DEVICE LEAKY" ALARM WAS ACTIVE ON THEIR BELLAVISTA 1000 UNIT. PATIENT INVOLVEMENT IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584035 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK IMTMEDICAL AG BELLAVISTA 1000

    Patients

    Seq Age Sex Outcome Treatment
    1