BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3903218 · Received June 30, 2014

    Report

    Report Number
    2031642-2014-00581
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Report Date
    June 4, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE OUT OF WARRANTY; NO REQUEST FOR MANUFACTURER'S SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WOULD OPERATE ON BACKUP BATTERY BUT WOULD NOT OPERATE ON AC POWER. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. AS THE DEVICE IS OUT OF WARRANTY, THE CUSTOMER CONTACTED MANUFACTURERS PRODUCT SUPPORT (PSE) FOR ASSISTANCE. PSE PROVIDED INFORMATION FOR REPLACEMENT OF THE POWER SUPPLY. THE FACILITY BIOMEDICAL ENGINEER REPORTED THE POWER SUPPLY AND POWER SWITCH WERE REPLACED. THE BIOMEDICAL ENGINEER REPORTED PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND THE UNIT IS READY FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380049 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1