BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 6216516 · Received December 30, 2016

    Report

    Report Number
    2021710-2016-05160
    Event Type
    Malfunction
    Date Received
    December 30, 2016
    Date of Event
    December 4, 2016
    Report Date
    May 26, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K093094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION: CAREFUSION FAILURE ANALYSIS LAB TECHNICIAN WAS ABLE TO VERIFY AND DUPLICATE THE CUSTOMER'S REPORTED ISSUE. THE EXHALATION DIFFERENTIAL PRESSURE TRANSDUCER FAILED CALIBRATION. THE ODV WAS OUTSIDE OF SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    CAREFUSION FILE IDENTIFICATION: (B)(4). (B)(4). CUSTOMER REPLACED THE MAIN BOARD OF THE REPORTED VENTILATOR. A RETURN MATERIALS AUTHORIZATIONS HAS BEEN PROVIDED TO THE CUSTOMER BUT THE SUSPECT MAINBOARD HASN'T BEEN RECEIVED AT THIS TIME BY CAREFUSION. IF THE DEVICE IS RETURNED THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER AN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR VELA VENTILATOR DISPLAYED A TRANSDUCER FAULT ALARM. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865264 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC VELA VENTILATOR

    Patients

    Seq Age Sex Outcome Treatment
    1