BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11996582 · Received June 14, 2021

    Report

    Report Number
    2031642-2021-04082
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Date of Event
    May 19, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838020054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER CONFIRMED DIAGNOSTIC ERROR CODE 1105-ALARM LED FAILURE. BIOMED IS REPORTING THE V60 IS DISPLAYING DIAGNOSTIC CODE EVEN AFTER REPLACING THE POWER SWITCH OVERLAY. ADVISED CUSTOMER THE RECOMMENDED REPAIR IS TO REPLACE THE POWER MANAGEMENT BOARD. THE CUSTOMER REPORTED THAT REPLACING THE POWER MANAGEMENT BOARD RESOLVED THE PROBLEM. ALTHOUGH REQUESTED TO BE RETURNED, THE REMOVED COMPONENT WAS NOT RECEIVED FOR EVALUATION AT THIS TIME. AN UPDATE REPORT WILL BE SUBMITTED IF THE PART IS RECEIVED AND EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE HAD AN ALARM LED (LIGHT EMITTING DIODE) FAILURE. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME OF THE EVENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885965 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown