BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 21756425 · Received April 2, 2025

    Report

    Report Number
    2518422-2025-041037
    Event Type
    Malfunction
    Date Received
    April 2, 2025
    Date of Event
    March 27, 2025
    Report Date
    April 18, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838009868
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E: (B)(6). PHONE: (B)(6).

    Additional Manufacturer Narrative · 0

    THIS CASE HAS BEEN IDENTIFIED TO BE A DUPLICATE TO ANOTHER CASE WITH MFR REF # 2518422-2025-031919.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THE BATTERY WAS NOT HOLDING THE CHARGE, AND THE DEVICE WAS NOT OPERATING IN BATTERY MODE. AT THIS TIME, IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED; HOWEVER, THERE WAS NO REPORTED HARM TO THE PATIENT OR USER. THE CUSTOMER CALLED TECHNICAL SUPPORT TO REPORT THAT THE BATTERY WAS NOT HOLDING THE CHARGE, AND THE DEVICE COULD NOT OPERATE IN BATTERY MODE. A SERVICE QUOTE FOR REPAIR WAS SENT TO THE CUSTOMER FOR APPROVAL. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1263396 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 00884838009868

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown