BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11740446 · Received April 28, 2021

    Report

    Report Number
    2031642-2021-03528
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    March 30, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838020054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON ADDITIONAL INFORMATION RECEIVED, THE FRONT BEZEL AND TOUCHSCREEN WERE REPLACED. THIS RESOLVED THE ISSUE FOR THE CUSTOMER. THE DEVICE REMAINS ONSITE AND IN USE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE TOUCHSCREEN WAS NOT WORKING ON THE BOTTOM OF THE SCREEN EVEN AFTER CALIBRATION AND THAT THE BEZEL WAS CRACKED. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME OF THE EVENT. THERE WAS NO REPORT OF PATIENT OR USER HARM/IMPACT. THE DEVICE WAS EVALUATED BY THE CUSTOMER WITH ASSISTANCE FROM A PHILIPS REMOTE SERVICE ENGINEER (RSE). THE RSE PROVIDED THE CUSTOMER WITH PART INFORMATION FOR A REPLACEMENT TOUCHSCREEN AND FRONT BEZEL ASSEMBLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636345 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown