BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 6075828 · Received November 3, 2016

    Report

    Report Number
    2031642-2016-02974
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Report Date
    October 10, 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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2016.

    Additional Manufacturer Narrative · 1

    THE FAILURE INVESTIGATION (FI) LAB RECEIVED THE BLOWER ASSEMBLY AND THE MOTOR CONTROLLER BRUSHLESS FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED BLOWER ASSEMBLY AND THE BRUSHLESS MOTOR CONTROLLER (BMC) REVEALED NO EVIDENCE OF DAMAGE OR CONTAMINATION. FI TECHNICIAN TESTED THE BLOWER ASSEMBLY AND BMC; NO FAILURES WERE IDENTIFIED. 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. THE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED DUE TO NO PROBLEM FOUND.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE DOING PERFORMANCE MAINTENANCE (PM), THERE WERE A COUPLE OF OCCASIONS WHEN THE UNIT WAS TURNED OFF AND IT TURNED BACK ON. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728416 ESPRIT VENTILATOR VENTILATOR CBK RESPIRONICS CALIFORNIA, INC V1000

    Patients

    Seq Age Sex Outcome Treatment
    1