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

Model Number	V60
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A service engineer was dispatched onsite to evaluate and repair the device.The service engineer inspected the device, confirmed the 110b error, and found that the device had a lot of volume leakage.The service engineer adjusted the data acquisition (da) printed circuit board assembly (pcba), but the issue remained.The service engineer then replaced the da pcba and successfully performed verification testing, after which the issue was resolved.The device passed the required performance verification tests per philips standard and was returned to service.
Event or Problem Description
Philips received a complaint from the customer on the v60 ventilator indicating that a 110b "proximal pressure sensor autozero failed" alarm error occurred.It was reported that there was no patient involvement at the time the issue was discovered.No patient or user harm was reported.The remote service engineer (rse) performed troubleshooting with the customer and found that the data acquisition (da) printed circuit board assembly (pcba) and solenoid valve may need to be replaced.The rse recommended replacing the solenoid valve, and if the issue persisted, the rse also suggested replacing the da pcba.A service quote consisting of the replacement da pcba and solenoid valve was sent to the customer for approval, and the customer accepted.

• 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 ; 7247330200
• MDR Report Key: 24622088
• Report Number: 2518422-2026-110656
• Device Sequence Number: 15913030
• Product Code: MNT
• UDI-Device Identifier: 00884838009844
• UDI-Public: (01)00884838009844
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

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: 1053613
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/07/2026
• Date Device Manufactured: 10/05/2015
• 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