BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 24904957 · Received April 16, 2026

    Report

    Report Number
    2518422-2026-112292
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Date of Event
    April 14, 2026
    Report Date
    May 6, 2026
    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

    THE BENCH SERVICE ENGINEER (BSE) STATED THAT THE UNIT HAD AN ALARM THAT INDICATED LOW LEAK CO2 REBREATHING RISK FAILURE. THE BSE RECOMMENDED REPLACEMENT OF THE GAS DELIVERY SYSTEM. THE BSE TESTED THE DEVICE BUT WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. THE DEVICE PASSED THE REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARDS AND WAS RETURNED TO SERVICE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT A LOW LEAK CO2 REBREATHING RISK FAILURE OCCURRED. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. IT WAS DISCOVERED AT BENCH REPAIR THAT A LOW LEAK CO2 REBREATHING RISK FAILURE OCCURRED. THE BENCH SERVICE ENGINEER (BSE) STATED THAT THE UNIT HAD AN ALARM THAT INDICATED THERE WAS A LEAK. THE BSE TEST THE EQUIPMENT AND CONFIRMED THERE WAS A LEAK AND THE ALARM WAS FOR A LOW LEAK CO2 REBREATHING RISK FAILURE. THE BSE DETERMINED A REPLACEMENT OF THE GAS DELIVERY SYSTEM (GDS) WAS REQUIRED. THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548981 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR

    Patients

    Seq Age Sex Outcome Treatment
    1