BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 6406125 · Received March 15, 2017

    Report

    Report Number
    2031642-2017-00928
    Event Type
    Malfunction
    Date Received
    March 15, 2017
    Report Date
    February 20, 2017
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE TOUCH SCREEN DID NOT FUNCTION. THE CABLE MMI TO TOUCH SCREEN WAS DEFECTIVE. THE CABLE WAS REPLACED AND THE DEVICE WAS TESTED AND RETURNED TO FULL FUNCTIONALITY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE UNIT FAILED SHORT SELF TEST (SST). THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187642 ESPRIT VENTILATOR VENTILATOR CBK RESPIRONICS CALIFORNIA, INC V1000

    Patients

    Seq Age Sex Outcome Treatment
    1