BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 19059810 · Received April 8, 2024

    Report

    Report Number
    2518422-2024-17966
    Event Type
    Malfunction
    Date Received
    April 8, 2024
    Date of Event
    March 14, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: G1 PHONE NUMBER (B)(6).

    Additional Manufacturer Narrative · 0

    THE CUSTOMER INFORMED THE REMOTE SERVICE ENGINEER (RSE) OF THE ISSUE AND REQUESTED THE PART NUMBERS REQUIRED FOR A REPAIR. THE RSE PROVIDED THE CUSTOMER WITH THE PART INFORMATION FOR THE 2ND GENERATION LIQUID CRYSTAL DISPLAY (LCD), 2ND GENERATION LCD CABLE, 2ND GENERATION USER INTERFACE (UI) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA), LCD TO UI PCBA CABLE, 2ND GENERATION LCD TRAY, AND SCREW PACK. MULTIPLE GOOD FAITH EFFORTS (GFE) WERE ATTEMPTED TO OBTAIN CONFIRMATION OF THE PART ORDER, PART REPLACEMENT, AND RESOLUTION. NO RESPONSE OR FURTHER INFORMATION WAS RECEIVED FROM THE CUSTOMER. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THE SCREEN WAS VERY DIM AND ADJUSTMENTS TO THE BRIGHTNESS DID NOT HELP. THE DEVICE WAS REPORTED TO BE OUTSIDE OF USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. THE CUSTOMER INFORMED THE REMOTE SERVICE ENGINEER (RSE) OF THE ISSUE AND REQUESTED THE PART NUMBERS REQUIRED FOR A REPAIR. THE RSE PROVIDED THE CUSTOMER WITH THE PART INFORMATION FOR THE 2ND GENERATION LIQUID CRYSTAL DISPLAY (LCD), 2ND GENERATION LCD CABLE, 2ND GENERATION USER INTERFACE (UI) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA), LCD TO UI PCBA CABLE, 2ND GENERATION LCD TRAY, AND SCREW PACK. THIS INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120689 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown