BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 17445995 · Received August 2, 2023

    Report

    Report Number
    2518422-2023-17696
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Date of Event
    December 16, 2022
    Report Date
    August 2, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838009851
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS PART OF A CORRECTIVE ACTION TO REPLACE MANUFACTURER REPORT # 2031642-2023-00136. ALL INFORMATION FROM THE ORIGINAL REPORT(S) HAS BEEN TRANSFERRED TO THIS REPORT.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT FROM THE FIELD SERVICE ENGINEER (FSE), REPORTING THAT THE V60 VENTILATOR HAD LOW SCREEN BRIGHTNESS. IT WAS UNKNOWN HOW THE ISSUE WAS FOUND. NO PATIENT OR USER HARM REPORTED. INSUFFICIENT INFORMATION IS AVAILABLE TO DETERMINE THE RESOLUTION OF THE EVENT. MULTIPLE GOOD FAITH EFFORTS WERE MADE TO RETRIEVE DEVICE EVALUATION, REPAIR, AND OPERATIONAL STATUS ON 12/22/2022, 01/11/2023, 01/19/2023, 01/25/2023, 02/01/2023, 02/07/2023, 02/14/2023, 02/21/2023, 02/28/2023, AND 03/08/2023, HOWEVER, YIELDED NO RESPONSE FROM THE CUSTOMER. IT IS UNKNOWN IF ANY PARTS OR REPAIRS HAVE BEEN CONDUCTED. THE COMPLAINT WILL BE PROCESSED FOR CLOSURE. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THE COMPLAINT WILL BE REOPENED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE KEY MARKET REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT WHEN THE ISSUE OCCURRED. NO PATIENT OR USER HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796466 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 00884838009851

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown