BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 20507111 · Received October 22, 2024

    Report

    Report Number
    2518422-2024-64575
    Event Type
    Malfunction
    Date Received
    October 22, 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

    H11: EVENT DATE WAS UPDATE TO: (B)(6) 2024. DATE RECEIVED BY MFG: 10/18/2024.

    Additional Manufacturer Narrative · 0

    H10: E1- (B)(6).

    Additional Manufacturer Narrative · 0

    FOLLOWING A REVIEW OF THE DEVICE DIAGNOSTIC REPORT (DRPT), IT HAS BEEN DETERMINED THAT THE DEVICE EXPERIENCED AN OVERVOLTAGE PROTECTION (OVP) CIRCUIT FAILURE. THE OVP FAILURE RESULTED IN THE DEVICE EXPERIENCING AN OVP CIRCUIT FAILED ERROR CODE, 5-VOLT FAILED ERROR CODE, 35-VOLT FAILED ERROR CODE, 3.3-VOLT FAILED ERROR CODE, AND A MACHINE AND PROXIMAL PRESSURE SENSORS FAILED ERROR CODE. DUE TO THE OVP CIRCUIT FAILURE, THE DEVICE MOTOR WOULD NOT TURN ON. IT WAS DETERMINED BY THE BENCH SERVICE ENGINEER THAT THE MOTOR CONTROLLER (MC) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) NEEDED TO BE REPLACED TO RESOLVE THE ISSUE. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    A BENCH SERVICE ENGINEER (BSE) EVALUATED THE DEVICE AT A PHILIPS BENCH SERVICE CENTER AND OBSERVED THE MACHINE AND PROXIMAL PRESSURE SENSORS FAILED ALARM. FOLLOWING A REVIEW OF THE DEVICE DIAGNOSTIC REPORT (DRPT), IT HAS BEEN DETERMINED THAT THE DEVICE EXPERIENCED AN OVERVOLTAGE PROTECTION (OVP) CIRCUIT FAILURE. THE OVP FAILURE RESULTED IN THE DEVICE EXPERIENCING AN OVP CIRCUIT FAILED ERROR CODE, 5-VOLT FAILED ERROR CODE, 35-VOLT FAILED ERROR CODE, 3.3-VOLT FAILED ERROR CODE, AND A MACHINE AND PROXIMAL PRESSURE SENSORS FAILED ERROR CODE. DUE TO THE OVP CIRCUIT FAILURE, THE DEVICE MOTOR WOULD NOT TURN ON. IT WAS DETERMINED BY THE BENCH SERVICE ENGINEER THAT THE MOTOR CONTROLLER (MC) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) NEEDED TO BE REPLACED TO RESOLVE THE ISSUE. ON 28JAN2025 THE BSE REPLACED THE MC PCBA TO RESOLVE THE OVP FAILURE AND THE ASSOCIATED 5-VOLT FAILED, 35-VOLT FAILED, 3.3-VOLT FAILED, AND A MACHINE AND PROXIMAL PRESSURE SENSORS FAILED ERROR CODES. 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.

    Additional Manufacturer Narrative · 0

    H11: CORRECTION TO (DEVICE) PROBLEM CODE GRID.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT A MACHINE AND PROXIMAL PRESSURE SENSORS 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 MACHINE AND PROXIMAL PRESSURE SENSORS FAILED ALARM AND DETERMINED THAT THE MOTOR CONTROLLER (MC) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) NEEDED TO BE REPLACED. THIS INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1958083 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown