BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 17876390 · Received October 5, 2023

    Report

    Report Number
    2518422-2023-25606
    Event Type
    Malfunction
    Date Received
    October 5, 2023
    Date of Event
    September 14, 2023
    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

    THE CUSTOMER CALLED IN TO REPORT THAT THERE WAS AN OVP CIRCUIT FAILURE. THE CUSTOMER EVALUATED THE DEVICE WITH THE ASSISTANCE OF THE REMOTE SERVICE ENGINEER (RSE) AND CONFIRMED THE REPORTED PROBLEM. A FIELD SERVICE ENGINEER (FSE) WENT ONSITE AND CONFIRMED THE REPORTED ISSUE. THE FSE REPLACED THE MOTOR CONTROLLER (MC) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) AND CONFIRMED THE REPORTED ISSUE WAS RESOLVED. THE FSE REPLACED THE MC PCBA 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.

    Additional Manufacturer Narrative · 0

    PRODUCT INVESTIGATION LAB (PIL) CONFIRMED THE OVP FAILED AND OTHER ALARMS WERE TRIGGERED DUE TO MC PCBA ANALOG TO DIGITAL CONVERTER (ADC) FAILURE.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THERE WAS A OVERVOLTAGE PROTECTOR (OVP) CIRCUIT FAILURE. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. 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 THERE WAS AN OVP CIRCUIT FAILURE. REPAIR IS CURRENTLY PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2272385 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR 00884838033832

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown