BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVEA VENTILATOR

    MDR report key: 7112859 · Received December 13, 2017

    Report

    Report Number
    2021710-2017-07126
    Event Type
    Injury
    Date Received
    December 13, 2017
    Date of Event
    November 21, 2017
    Report Date
    March 2, 2018
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    CBK
    PMA / PMN Number
    K103211
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE HARDWARE HAD BEEN RECEIVED AT THE TIME OF THE INITIAL SUBMISSION BUT THE REPORT SUBMISSION WAS NOT SUBMITTED IN ERROR. THIS WAS IDENTIFIED ON 02FEB2018. RESULTS OF INVESTIGATION: THE VYAIRE MEDICAL FAILURE ANALYSIS LABORATORY RECEIVED THE SUSPECT SECONDARY ALARM COMPONENT FOR INVESTIGATION. THE FA LABORATORY PERFORMED A VISUAL AND PHYSICAL INSPECTION, WHICH FOUND NO ANOMALIES. THE ALARM COMPONENT WAS PLACED ON TEST BENCH AND CYCLED ON, THE FA LABORATORY FOUND NO ALARM COMPONENT FAILURE. THE INVESTIGATION COULD NOT DUPLICATE THE REPORTED EVENT AND COULD NOT ISOLATE THE ISSUE TO THE ALARM COMPONENT. THEREFORE, NO COMPONENT ROOT CAUSE COULD BE DETERMINED. THIS ISSUE WILL BE INTERNALLY INVESTIGATED WITHIN VYAIRE MEDICAL.

    Additional Manufacturer Narrative · 1

    THE DEVICE TRAINED CUSTOMER REPORTED EVALUATING THE SUSPECT DEVICE AND REPORTED DUPLICATING THE EVENT, WHICH HE ISOLATED TO THE SECONDARY ALARM. THE CUSTOMER REPORTED ORDERING A REPLACEMENT SECONDARY ALARM COMPONENT. AT THIS TIME, VYAIRE MEDICAL HAS NOT RECEIVED THE SUSPECT COMPONENT FOR EVALUATION. IN THE EVENT THAT THE DEVICE IS RECEIVED FOR EVALUATION OR ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INTERMITTENT SECONDARY AUDIBLE ALARM MALFUNCTION WITH THIS DEVICE DURING PATIENT USE. THE CUSTOMER STATED NO PATIENT HARM OR INJURY WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894483 AVEA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC AVEA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention