BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 20965212 · Received December 18, 2024

    Report

    Report Number
    2518422-2024-074931
    Event Type
    Malfunction
    Date Received
    December 18, 2024
    Date of Event
    December 3, 2024
    Report Date
    December 20, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SERVICE ENGINEER (SE) EVALUATED THE DEVICE AND REPORTED THAT THE DEVICE PASSED TESTING, AND NO OTHER ISSUES WERE FOUND. THE SE CONFIRMED THAT ERROR CODE 1127 (OVERVOLTAGE PROTECTION CIRCUIT FAILED) WAS LOGGED IN THE EVENT LOG. THE SE REPORTED THAT THE MOTOR CONTROL BOARD WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE WOULD BE TESTED IN ACCORDANCE WITH THE SERVICE MANUAL. THE UNIT HAS BEEN RETURNED TO SERVICE.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER, REPORTING THAT THE V60 VENTILATOR DISPLAYED ERROR CODE 1127 (OVERVOLTAGE PROTECTION (OVP) CIRCUIT FAILED). THE DEVICE WAS IN CLINICAL USE WHEN THE ISSUE OCCURRED; THE PATIENT WAS MOVED TO A DIFFERENT VENTILATOR, AND THE SUSPECTED DEVICE WAS REMOVED FROM SERVICE. NO PATIENT OR USER HARM REPORTED. A PHILIPS REMOTE SERVICE ENGINEER (RSE) NOTED THAT THE CUSTOMER'S V60 VENTILATOR DISPLAYED ERROR CODE 1127 (OVP CIRCUIT FAILED). THE RSE NOTED THAT THE ISSUE AFFECTED THE 12 VOLT AND 3.3-VOLT OVP CIRCUIT AND DID NOT DETECT A 3.3 V OVER-VOLTAGE CONDITION WITHIN 100 MILLISECONDS (MSEC) AFTER THE 3.3 V, AND THE 12 V OVP TEST SIGNAL WAS ENABLED. THE RSE ALSO NOTED THAT THE 3.3 V AND/OR 12 V OVP TEST SIGNAL WAS ENABLED LONGER THAN 200 MSEC. THE RSE RECOMMENDED REPLACING THE MOTOR CONTROL (MC) BOARD, AND POWER MANAGEMENT (PM) BOARD. THE CUSTOMER WAS PROVIDED WITH THE PART NUMBERS FOR REPLACEMENT, BUT THE CUSTOMER REQUESTED ONSITE SERVICE. THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2022513 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown