MAUDE Adverse Event Report: RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS USE, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number	V60
Medical Device Problem Code	Inadequate User Interface (2958)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint by a biomedical engineer (bme) on the v60 (software version 3.10) indicating that the liquid crystal display (lcd) needed to be replaced.It was reported that there was no patient involvement at the time the issue was discovered.No patient or user harm was reported.As of june 15, 2026, an authorized service provider (asp) was dispatched onsite to evaluate and repair the device, and upon arrival, the asp performed test and verification (t&v) tests per the v60 service manual and calibrated lcd screen.The asp found that the liquid crystal display (lcd) was not functioning; however, the touchscreen was able to be calibrated and recognize touches.No error codes/error messages were encountered by the user, and no accessories, including third-party devices, were being used that may have contributed to the issue.Ultimately, the asp found that the cause of the malfunction was due to a faulty nec lcd cable that needed to be replaced for repair; after performing the replacement, the asp verified that the issue was resolved.The investigation concludes that no further action is required at this time.

• Brand Name: RESPIRONICS
• Common Device Name: VENTILATOR, CONTINUOUS USE, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 25669536
• Report Number: 2518422-2026-114278
• Device Sequence Number: 13376671
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)00884838020054
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K102985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 06/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 06/30/2026
• Date Device Manufactured: 12/27/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown