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

Model Number	V60 V60Plus Ventilator
Medical Device Problem Code	Failure to Shut Off (2939)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint by an authorized service provider (asp) on the v60 indicating a device malfunction as the device failed to turn on and off and needed to have the front bezel replaced.There was no patient involvement at the time the issue was discovered.No patient or user harm was reported.The asp performed annual preventive maintenance (pm) and confirmed that the device could not be powered on and off as the on/off switch was not working.No accessories, including third-party devices, were being used that may have contributed to the issue.The asp performed a complete performance verification test (pvt) per the manufacturer's specifications, checked the settings and event logs, and concluded that the issue originated from a faulty front bezel.Ultimately, the asp replaced the front bezel and user interface (ui) to power management (pm) cable, after which the issue was resolved.After installed the replacement parts, the asp performed pvt, verified that the device passed all tests and calibrations and returned the device 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.Based on the case information provided and/or service performed, it was confirmed that the device did not meet product specifications.The alleged malfunction impacted the user¿s ability to use the device properly.

• Brand Name: Respironics
• Common Device Name: Ventilator, Continuous, 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 ; 1001 murry ridge lane; murrysville, PA 15668 ; +1(724)733-0200
• MDR Report Key: 50946358
• Report Number: 2518422-2026-115489
• Device Sequence Number: 18529759
• 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,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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 V60Plus Ventilator
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 12/13/2018
• 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