BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 6144464 · Received December 5, 2016

    Report

    Report Number
    2031642-2016-03314
    Event Type
    Malfunction
    Date Received
    December 5, 2016
    Report Date
    November 9, 2016
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THROUGH FOLLOW-UPS, THE KEY MARKET (KM) INDICATED THAT THE REPORTED PROBLEM WAS CONFIRMED. FSE IDENTIFIED THAT THE POWER SUPPLY WAS DEFECTIVE. THE FSE REPLACED THE POWER SUPPLY AND THE MAIN HARNESS TO ADDRESS THE REPORTED PROBLEM. THE UNIT WAS RETURNED TO SERVICE. THE DETERMINATION COULD NOT BE MADE THAT THE DEVICE FAILED TO MEET SPECIFICATIONS. THE DEVICE WAS NOT BEING USED FOR TREATMENT WHEN THE REPORTED EVENT OCCURRED, AND THERE IS A RELATIONSHIP OF THE DEVICE TO THE REPORTED PROBLEM. NO PARTS RETURNED TO FAILURE INVESTIGATION; THEREFORE, THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IF PARTS ARE RETURNED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE UNIT WAS NOT SWITCHING ON. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795030 ESPRIT VENTILATOR VENTILATOR CBK RESPIRONICS CALIFORNIA, INC V1000

    Patients

    Seq Age Sex Outcome Treatment
    1