BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 23908595 · Received December 29, 2025

    Report

    Report Number
    2518422-2025-059109
    Event Type
    Malfunction
    Date Received
    December 29, 2025
    Date of Event
    December 5, 2025
    Report Date
    January 30, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER A GOOD FAITH EFFORT (GFE) RESPONSE RECEIVED, BOTH SPEAKERS WERE REPLACED, AND A FULL PREVENTIVE MAINTENANCE (PM) AND TEST-OUT WERE PERFORMED. THE DEVICE PASSED ALL FUNCTIONAL TESTS AND WAS RETURNED TO SERVICE.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER REPORTING A PRIMARY ALARM FAILED MESSAGE OCCURRED ON THE V60 VENTILATOR. THE DEVICE WAS NOT IN CLINICAL USE. THERE WAS NO REPORT OF HARM. THERE WAS NO PATIENT IMPACT. THE DEVICE DID NOT MEET SPECIFICATION FOR INTENDED USE AND WAS REMOVED FROM SERVICE. A PHILIPS REMOTE SERVICE ENGINEER (RSE) EVALUATED THE ISSUE WITH THE BIOMEDICAL ENGINEER (BME) AND CONFIRMED THE REPORTED ISSUE. THE BME VERBALLY VERIFIED TO THE RSE THE DIAGNOSTIC CODE 1102 (PRIMARY ALARM FAILED) APPEARED IN THE DEVICE EVENT LOG. THE RSE RECOMMENDED REPLACING THE SPEAKER. DUE TO THE DEVICE SOFTWARE VERSION OF 2.10, THE RSE WAS UNABLE TO DETERMINE WHICH SPEAKER. A PART NUMBER WAS SUPPLIED TO THE CUSTOMER FOR PART REPLACEMENT ORDER. IN REVIEW OF THE PROVIDED EVENT LOG, THE REPORTED DIAGNOSTIC CODE 1102 WAS NOT FOUND. FURTHERMORE, ACTIVITY FROM THE REPORTED EVENT DATE OF DECEMBER 05, 2025, WAS NOT FOUND. PER THE LOG AS PROVIDED, THE DEVICE WAS NOT POWERED ON BETWEEN NOVEMBER 21, 20025 AND DECEMBER 10, 2025. THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2848111 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown