BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3881984 · Received June 18, 2014

    Report

    Report Number
    2031642-2014-00509
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Report Date
    May 21, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADVISED CUSTOMER TO REPLACED THE POWER SUPPLY. CUSTOMER DECLINED REPAIR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WOULD NOT TURN ON VIA AC POWER AND THE MAINS POWER LED INDICATOR WAS NOT LIT. THE CUSTOMER REPORTED THE VENTILATOR WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) VERIFIED THE REPORTED PROBLEM. THE MANUFACTURERS FSE ADVISED THE CUSTOMER REPLACE THE POWER SUPPLY TO CORRECT THE REPORTED PROBLEM. THE CUSTOMER REFUSED REPAIR SERVICE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359282 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1