BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 18255753 · Received December 4, 2023

    Report

    Report Number
    2518422-2023-33262
    Event Type
    Malfunction
    Date Received
    December 4, 2023
    Date of Event
    November 9, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 AN ERROR CODE FOR OVP FAILURE HAD OCCURRED. THE RSE ADVISED THE REPLACEMENT OF THE MOTOR CONTROLLER (MC) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). THE RSE PROVIDED THE CUSTOMER WITH THE PART NUMBER OF THE MC PCBA. MULTIPLE ATTEMPTS HAVE BEEN MADE TO TRY TO OBTAIN FURTHER INFORMATION ABOUT THIS CASE BUT NO RESPONSE RECEIVED FROM THE CUSTOMER.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THERE WAS AN OVER VOLTAGE PROTECTION (OVP) 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 AN ERROR CODE FOR OVP FAILURE HAD OCCURRED. THE RSE ADVISED THE REPLACEMENT OF THE MOTOR CONTROLLER (MC) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). THE RSE PROVIDED THE CUSTOMER WITH THE PART NUMBER OF THE MC PCBA. THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1538733 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown