BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 6192610 · Received December 21, 2016

    Report

    Report Number
    2031642-2016-03535
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Report Date
    November 24, 2016
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE NURSE CALL FUNCTION WAS NOT WORKING. IT IS UNKNOWN IF THE UNIT WAS IN CLINICAL AT THE TIME THE REPORTED ISSUE WAS DISCOVERED; HOWEVER, CUSTOMER REPORTED THERE WAS NO HARM TO THE PATIENT OR THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846409 ESPRIT VENTILATOR VENTILATOR CBK RESPIRONICS CALIFORNIA, INC V1000

    Patients

    Seq Age Sex Outcome Treatment
    1