BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 6092663 · Received November 10, 2016

    Report

    Report Number
    2031642-2016-03065
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Report Date
    October 14, 2016
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT/USER INVOLVEMENT: THROUGH FOLLOW-UPS, CUSTOMER STATED THERE WAS NO PATIENT INVOLVEMENT. CONCLUSION: THE DETERMINATION COULD NOT BE MADE THAT THE DEVICE FAILED TO MEET SPECIFICATIONS. THE DEVICE WAS BEING USED FOR TREATMENT WHEN THE REPORTED EVENT OCCURRED, AND THERE IS A RELATIONSHIP OF THE DEVICE TO THE REPORTED PROBLEM. ROOT CAUSE: DUE TO PART WAS NOT RETURNED FOR FAILURE INVESTIGATION (FI); THEREFORE, NO ROOT CAUSE COULD BE DETERMINED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE BACKUP BATTERY WAS NOT CHARGING. THE UNIT WAS IN CLINICAL AT THE TIME THE REPORTED ISSUE WAS DISCOVERED; HOWEVER, THERE WAS NO HARM TO THE PATIENT OR THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743996 ESPRIT VENTILATOR VENTILATOR CBK RESPIRONICS CALIFORNIA, INC V1000

    Patients

    Seq Age Sex Outcome Treatment
    1