BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 21344641 · Received February 10, 2025

    Report

    Report Number
    2518422-2025-014068
    Event Type
    Malfunction
    Date Received
    February 10, 2025
    Date of Event
    January 24, 2025
    Report Date
    April 30, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP WAS PERFORMED WITH THE SERVICE ENGINEER (SE), AND IT WAS REPORTED THAT DATA ACQUISITION (DA) BOARD, MOTOR CONTROL (MC) BOARD, AND DA TO MC PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) CABLE WAS REPLACED. THE ISSUE WAS RESOLVED, AND THE DEVICE WAS RETURNED TO CLINICAL USE.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER, REPORTING THAT THE V60 VENTILATOR WAS INOPERABLE. THERE WAS NO PATIENT INVOLVEMENT WHEN THE ISSUE OCCURRED. NO PATIENT OR USER HARM REPORTED. A PHILIPS REMOTE SERVICE ENGINEER (RSE) NOTED THAT THE CUSTOMER'S V60 VENTILATOR WAS INOPERABLE. ONSITE SERVICE WAS REQUESTED. A FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE AND REPORTED THAT THE DEVICE DISPLAYED THE FOLLOWING ERROR CODES 1007, 106, 1107, 1110, 110E, 110F, 1113, 1127. BASED OFF THE MULTIPLE ERROR CODES REPORTED, THE ISSUE IS CONSIDERED A SPI (SERIAL PERIPHERAL INTERFACE) BUS FAILURE. THE FSE ALSO OBSERVED THE GAS DELIVERY SYSTEM (GDS) INFORMATION WAS NOT PRESENT ON THE SCREEN, WHILE IN SERVICE MODE. A CHECK WAS PERFORMED TO ENSURE THAT ALL THE CONNECTIONS WERE PROPERLY CONNECTED BETWEEN THE DATA ACQUISITION (DA) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA), MOTOR CONTROL (MC) PCBA, AND POWER MANAGEMENT (PM) PCBA. THE FSE REPORTED THAT THE DEVICE STILL POWERED ON WITH THE VENT INOPERATIVE CODE 1007. THE FSE THEN ATTEMPTED TO DISCONNECT, AND RECONNECT THE DA PCBA TO MC PCBA CABLE, AND THE DEVICE WAS ABLE TO POWER ON IN NORMAL VENTILATION MODE. THE FSE DETERMINED THE CABLE HAD A SHORT, AND THE ISSUE WAS INTERMITTENT. THE FSE NOTED THAT THE RECOMMENDED REPAIR PER THE SERVICE MANUAL, WAS TO REPLACE THE DA PCBA TO MC PCBA CABLE, DA PCBA, MC PCBA, PM PCBA. THIS INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1657306 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown