BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 24120630 · Received January 20, 2026

    Report

    Report Number
    2518422-2026-100169
    Event Type
    Malfunction
    Date Received
    January 20, 2026
    Date of Event
    January 14, 2026
    Report Date
    May 7, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838089280
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED, AND THE SERVICE ENGINEER (SE) NOTED THAT THE DEVICE DISPLAYED A "CHECK VENT: MACHINE PRESSURE SENSOR AUTO ZERO FAILED" ERROR CODE (1109). THE SE NOTED THAT THE DEVICE STOPPED DUE TO THE ERROR CODE.

    Additional Manufacturer Narrative · 0

    A SERVICE ENGINEER (SE) EVALUATED AND REPAIRED THE DEVICE AND REPORTED THAT THE FOLLOWING PARTS WERE REPLACED TO RESOLVE THE REPORTED ISSUE: DATA ACQUISITION (DA) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA), SOLENOID VALVE, AND O-RING. THE SE THEN NOTED THAT THE DEVICE WAS OPERATIONAL. THE SYSTEM MEETS THE SPECIFICATION FOR THE SERVICE PERFORMED AND IS RETURNED TO USE.

    Additional Manufacturer Narrative · 0

    INFORMATION WAS RECEIVED THAT THE DEVICE WAS NOT IN USE WHEN THE ISSUE OCCURRED. REPAIR INFORMATION IS STILL PENDING.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER, REPORTING THAT THE V60 VENTILATOR WAS INOPERABLE (NOT SPECIFIED). IT WAS UNKNOWN HOW THE ISSUE WAS FOUND. THERE WAS NO PATIENT OR USER HARM REPORTED. A SERVICE ENGINEER (SE) IS BEING DISPATCHED TO THE CUSTOMER'S SITE. THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183212 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 00884838089280

    Patients

    Seq Age Sex Outcome Treatment
    1