BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 12038142 · Received June 21, 2021

    Report

    Report Number
    2031642-2021-04148
    Event Type
    Malfunction
    Date Received
    June 21, 2021
    Date of Event
    May 27, 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 CUSTOMER REPLACED THE POWER SWITCH OVERLAY TO RESOLVE THE REPORTED ISSUE. THE DEVICE PASSED REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS¿S STANDARDS.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED INTO TECHNICAL SUPPORT (TS) REPORTING THAT THE DEVICE DISPLAYS ALARM LED FAILED MESSAGE. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. THE CUSTOMER EVALUATED THE DEVICE WITH THE ASSISTANCE OF THE REMOTE SERVICE ENGINEER (RSE) AND CONFIRMED THE REPORTED PROBLEM. THE RSE ADVISED THE CUSTOMER TO REPLACE THE POWER SWITCH OVERLAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934060 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown