BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 20538184 · Received October 25, 2024

    Report

    Report Number
    2518422-2024-66020
    Event Type
    Malfunction
    Date Received
    October 25, 2024
    Date of Event
    October 18, 2024
    Report Date
    February 4, 2025
    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

    A BENCH SERVICE ENGINEER (BSE) EVALUATED THE DEVICE AT A PHILIPS BENCH SERVICE CENTER. THE BSE OBSERVED THE BATTERY ISSUE AND DETERMINED THAT THE BACKUP BATTERY NEEDED TO BE REPLACED. IN ADDITION TO THE ISSUES OBSERVED WITH THE BATTERY, IT WAS FOUND THAT THE BATTERY EXCEEDED THE RECOMMENDED FIVE YEARS OF USE. ON 28JAN2025, THE BSE REPLACED THE BATTERY TO RESOLVE THE BATTERY FAILURE. FOLLOWING THE PART REPLACEMENT THE BSE COMPLETED A PERFORMANCE VERIFICATION TEST (PVT) WHICH THE DEVICE PASSED, CONFIRMING A RETURN TO FULL FUNCTIONALITY. THE BSE RESTORED THE DEVICE TO FACTORY SETTINGS PRIOR TO SENDING THE DEVICE BACK TO THE CUSTOMER READY FOR USE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. PER V60 SERVICE MANUAL: RECOMMENDED REPLACEMENT EVERY 5 YEARS BASED ON THE DATE OF MANUFACTURE RECORDED ON THE BATTERY LABEL.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THE BATTERY DID NOT CHARGE, AND A BATTERY FAILED ALARM OCCURRED. THE DEVICE WAS REPORTED TO BE OUTSIDE OF USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. A BENCH SERVICE ENGINEER (BSE) EVALUATED THE DEVICE AT A PHILIPS BENCH SERVICE CENTER. THE BSE OBSERVED THE BATTERY ISSUE AND DETERMINED THAT THE BACKUP BATTERY NEEDED TO BE REPLACED. IN ADDITION TO THE ISSUES OBSERVED WITH THE BATTERY, IT WAS FOUND THAT THE BATTERY EXCEEDED THE RECOMMENDED FIVE YEARS OF USE. THIS INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2026407 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown