MAUDE Adverse Event Report: Respironics, Inc. Respironics; Ventilator, Continuous use, Minimal Ventilatory Support, Facility Use

Model Number	V60
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint by the customer on the v60 indicating a device malfunction as the screen was not working properly.There was no patient involvement at the time the issue was discovered as the issue occurred during preventive maintenance (pm) evaluation.No patient or user harm was reported.The customer called technical support to report that the liquid crystal display (lcd) assembly, nec lcd cable, user interface (ui) printed circuit board assembly (pcba) to lcd cable, ui pcba, and lcd tray needed to be ordered.Per the customer communication on (b)(6)2026, the parts were used to address an improperly working screen.The v60 service manual (revision t) was used in diagnosing the issue.Once the lcd assembly, nec lcd cable, ui pcba to lcd cable, ui pcba, and lcd tray were replaced, the issue was resolved as the device operated as intended per the manufacturer's specifications.The device passed the required performance verification tests per philips standard and was returned to service.No other malfunction was found.The investigation concludes that no further action is required at this time.If additional information is received, the complaint file will be reopened.

• 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 ; +1(412)542-3300
• MDR Report Key: 50304332
• Report Number: 2518422-2026-114961
• Device Sequence Number: 10247021
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)00884838020054
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/18/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 08/18/2026
• Date Device Manufactured: 12/09/2011
• 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