BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 4132484 · Received October 1, 2014

    Report

    Report Number
    2031642-2014-01121
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 4, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER ATTEMPTS TO GAIN MORE INFORMATION FROM CUSTOMER HAVE YIELDED NO RESPONSE.

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THE POWER SUPPLY DEFECTIVE. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT HARM REPORTED. FURTHER ATTEMPTS TO GATHER MORE INFORMATION FROM THE CUSTOMER HAS YIELDED NO RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612019 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1