BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 17247884 · Received July 3, 2023

    Report

    Report Number
    2518422-2023-14694
    Event Type
    Malfunction
    Date Received
    July 3, 2023
    Date of Event
    June 8, 2023
    Report Date
    July 15, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    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

    A FIELD SERVICE ENGINEER (FSE) WENT ONSITE AND CONFIRMED THE REPORTED ISSUE. THE FSE REPLACED THE CENTRAL PROCESSING UNIT (CPU) BOARD TO RESOLVE THE REPORTED ISSUE. THE DEVICE PASSED 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 THE COMPLAINT FILE WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    A CPU WAS RETURNED FOR ANALYSIS. THE RESULTS OF THE TESTING OF THIS CPU HAS RESULTED IN A NO PROBLEM FOUND.

    Additional Manufacturer Narrative · 0

    H10: E1 INITIAL REPORTER GENTLENESS MANKIND MEDICAL CO.,LTD. KUMAMOTO OFFICE (B)(6).

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT A "CHECK VENT: BACKUP ALARM FAILED" WENT OFF. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME THE REPORTED ISSUE WAS DISCOVERED; HOWEVER, THERE WAS NO HARM TO THE PATIENT OR USER. THE DEVICE WAS SWAPPED OUT WITH A DIFFERENT DEVICE. NO MEDICAL INTERVENTION PROVIDED TO THE PATIENT NOR A DELAY WAS NOTED. THE CUSTOMER EVALUATED THE DEVICE WITH THE ASSISTANCE OF THE REMOTE SERVICE ENGINEER (RSE) AND CONFIRMED THE REPORTED PROBLEM. THE CUSTOMER CALLED IN TO REPORT THAT A "CHECK VENT: BACKUP ALARM FAILED" WENT OFF. THE RSE CONFIRMED THE ERROR CODE 1104, "CHECK VENT: BACKUP ALARM FAILED", HAD OCCURRED IN THE EVENT LOGS. THE RSE DETERMINED THAT THE CENTRAL PROCESSING UNIT (CPU) BOARD WAS FAULTY AND REQUIRED A REPLACEMENT. ONSITE REPAIR IS CURRENTLY PENDING CUSTOMER ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1252925 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown