BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11770783 · Received May 4, 2021

    Report

    Report Number
    2031642-2021-03579
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    April 5, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838020054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SPEAKER ON THE MOTOR CONTROLLER BOARD WAS REPLACED BY A PHILIPS SERVICE ENGINEER. ALL REQUIRED TESTS PASSED. THE SYSTEM FULLY MET THE SPECIFICATION AND WAS RETURNED FOR USE. THE REPLACED SPEAKER ASSEMBLY WAS RETURNED FOR FAILURE INVESTIGATION. THE SPEAKER ASSEMBLY WAS TESTED, AND NO FAILURES WERE IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ALARM FAILED. THE CUSTOMER CONTACTED PRODUCT SUPPORT AND WHILE TROUBLESHOOTING WITH CUSTOMER, VERIFIED THERE WAS A CHECK VENT ERROR CODE IN THE SIGNIFICATE LOG. THE CUSTOMER REPORTED THAT THE UNIT WAS NOT IN USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666298 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown