BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 6180388 · Received December 16, 2016

    Report

    Report Number
    2031642-2016-03485
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Report Date
    November 22, 2016
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAILURE INVESTIGATION (FI) LAB RECEIVED THE SENSOR PCBA FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED SENSOR BOARD REVEALED NO EVIDENCE OF DAMAGE OR CONTAMINATION. THE SENSOR PCBA WAS TESTED INTO THE FI TEST VENTILATOR. A FUNCTIONAL INTEGRITY ON AC POWER AND BACKUP BATTERY TEST WAS PERFORMED. NO FAILURES WERE IDENTIFIED; THEREFORE, THE REPORTED PROBLEM COULD NOT BE CONFIRMED. THE DETERMINATION COULD NOT BE MADE THAT THE DEVICE FAILED TO MEET SPECIFICATIONS. THE DEVICE WAS NOT BEING USED FOR TREATMENT WHEN THE REPORTED EVENT OCCURRED, AND THERE IS A RELATIONSHIP OF THE DEVICE TO THE REPORTED PROBLEM. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED DUE TO NO PROBLEM FOUND.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR SCREEN WENT BLUE THEN INOP. THE UNIT WAS IN CLINICAL AT THE TIME THE REPORTED ISSUE WAS DISCOVERED; HOWEVER, THERE WAS NO HARM TO THE PATIENT OR THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831593 ESPRIT VENTILATOR VENTILATOR CBK RESPIRONICS CALIFORNIA, INC V1000

    Patients

    Seq Age Sex Outcome Treatment
    1