BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 21461878 · Received February 25, 2025

    Report

    Report Number
    2518422-2025-022360
    Event Type
    Malfunction
    Date Received
    February 25, 2025
    Date of Event
    February 10, 2025
    Report Date
    March 3, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON FURTHER INVESTIGATION, IT WAS FOUND THAT THE ISSUE WAS ALREADY REPORTED ON MFR REPORT NUMBER 2518422-2025-011154. THEREFORE, THIS CASE WAS REPORTED IN ERROR AND IS BEING REDACTED.

    Additional Manufacturer Narrative · 0

    H10: E1: (B)(6).

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT BY THE FIELD SERVICE ENGINEER (FSE) ON THE V60 INDICATING THAT A 1127 "OVER VOLTAGE PROTECTION (OVP) CIRCUIT FAILED" ERROR OCCURRED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. NO PATIENT OR USER HARM WAS REPORTED. THE FIELD SERVICE ENGINEER (FSE) DISCOVERED THAT A 1127 "OVP CIRCUIT FAILED" ERROR OCCURRED. A SERVICE QUOTE FOR REPAIR WAS SENT TO THE CUSTOMER FOR APPROVAL. THE INVESTIGATION IS ONGOING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029261 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown