BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 19820617 · Received July 24, 2024

    Report

    Report Number
    2518422-2024-46877
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Date of Event
    July 15, 2024
    Report Date
    September 16, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE CUSTOMER REPLACED 2ND GEN LIQUID-CRYSTAL DISPLAY (LCD) 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. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. H11: D4 - PRODUCT UDI.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THE DEVICE BOOTS UP, BUT DISPLAY IS BLANK. UNIT IS STILL OPERATING FINE. 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 HAS A 1ST GENERATION LIQUID-CRYSTAL DISPLAY (LCD), AND THE RSE PROVIDED HIM THE PARTS IDS AND PRICING NEEDED TO UPGRADE IT TO 2ND GENERATION LCD. THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2370812 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown