BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 25233415 · Received May 20, 2026

    Report

    Report Number
    2518422-2026-113100
    Event Type
    Malfunction
    Date Received
    May 20, 2026
    Date of Event
    May 2, 2026
    Report Date
    May 20, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838033832
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E: SANSEI MEDICAL EQUIPMENT CO., LTD. FUKUSHIMA SUPPLY CENTER DELIVERY DESTINATION 45-1 HACHIMANZUKA, SHIMOTORIWATARI FUKUSHIMA CITY FUKUSHIMA PREFECTURE 960-1106 JAPAN PHONE: 024-544-2478.

    Description of Event or Problem · 0

    IT WAS REPORTED BY FACILITY MEDICAL ENGINEER A PHILIPS RESPIRONICS V60 VENTILATOR TURNED ITSELF OFF AND RESTARTED UNEXPECTEDLY WHILE IT WAS ACTIVELY BEING USED ON A PATIENT. A "RESTART" MESSAGE APPEARED ON THE SCREEN, AND THE DEVICE THEN WENT BACK TO NORMAL OPERATION. THE PATIENT WAS QUICKLY MOVED TO A DIFFERENT VENTILATOR. THERE WAS NO DELAY IN THERAPY, NO MEDICAL INTERVENTION WAS NEEDED, AND NO HARM OR INJURIES OCCURRED. THE HOSPITAL STAFF WAS BLOCKED FROM USING THE MACHINE, SO THEY IMMEDIATELY REMOVED IT FROM SERVICE AND SENT IT TO BE FIXED. A SERVICE ENGINEER TESTED THE DEVICE BUT COULD NOT MAKE THE RESTART HAPPEN AGAIN ON THE TEST BENCH. HOWEVER, WHEN THEY CHECKED THE MACHINE¿S INTERNAL COMPUTER HISTORY LOGS, THEY CONFIRMED THE MALFUNCTION HAPPENED. THE COMPUTER LOGGED TWO CODES AT THE EXACT SAME TIME: CODE 1101 (WHICH MEANS THE VENTILATOR RESTARTED BECAUSE IT HIT A PROCESSING ERROR) AND CODE 3007. CODE 1101 HAPPENS WHEN THE VENTILATOR'S MAIN COMPUTER BRAIN GETS CONFUSED BY UNREADABLE DATA, A PROGRAM GLITCH, OR A SOFTWARE ERROR. WHEN THIS HAPPENS, THE MACHINE IS DESIGNED TO QUICKLY RESTART ITSELF TO CLEAR ITS MEMORY AND FIX THE PROBLEM. NORMALLY, A CODE 1101 REQUIRES A TECHNICIAN TO REPLACE THE MAIN COMPUTER BOARD AND REINSTALL THE SOFTWARE. HOWEVER, THE MANUFACTURER'S MANUAL STATES THAT IF CODE 1101 IS PAIRED WITH CODE 3007, IT MEANS THE MACHINE SUCCESSFULLY FIXED ITSELF DURING THE REBOOT. THEREFORE, NO PHYSICAL REPAIRS WERE NEEDED. BECAUSE THE VENTILATOR'S BUILT-IN SAFETY SOFTWARE SUCCESSFULLY CLEARED THE GLITCH AND THE MACHINE PASSED ALL FOLLOW-UP SAFETY TESTS, THE SERVICE CENTER VERIFIED IT WAS SAFE TO USE AND RETURNED IT TO THE HOSPITAL READY FOR PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557033 RESPIRONICS VENTILATOR, CONTINUOUS USE, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 00884838033832

    Patients

    Seq Age Sex Outcome Treatment
    1