BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3900050 · Received June 27, 2014

    Report

    Report Number
    2031642-2014-00564
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Report Date
    June 2, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLETION OF SERVICE PENDING. OUT OF WARRANTY; NO REQUEST FOR MFR SERVICE.

    Description of Event or Problem · 1

    CUSTOMER DID NOT RESPOND TO MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WOULD NOT POWER ON AND HAD NO POWER LED INDICATORS FOR AC OR BATTERY. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE CUSTOMER REPORTED CHECK OF THE AC LINE AND BREAKERS WERE OK. THE FACILITY BIOMEDICAL ENGINEER REPORTED COMPLETION OF SERVICE IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378232 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1