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

Model Number	V60
Medical Device Problem Code	Power Problem (3010)
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 regarding a v60 ventilator that displayed an auxiliary alarm supply failed alarm, though no patient or user harm was reported.At the time of the incident, the device was reported to be outside of use.During remote troubleshooting, the customer informed the remote service engineer (rse) that they checked the voltages on the pneumatics screen and noted no issues.Because the product malfunction could not be definitively confirmed remotely, the rse reviewed the v60 service manual and determined that a faulty motor controller (mc) printed circuit board assembly (pcba) was the likely cause of the alleged issue.The rse then recommended replacing the mc pcba and provided the necessary part information.In a good faith effort response received on june 29, 2026, the customer confirmed that the part was ordered, received, and successfully installed.Following the component replacement, the customer completed performance testing in accordance with the service manual, and the device was confirmed to be fully functional and returned to use.Consequently, the investigation concludes that no further action is required at this time, though the complaint file will be reopened if additional information is received.

• 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: 25668480
• Report Number: 2518422-2026-114276
• Device Sequence Number: 21444442
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)00884838020054
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 10/19/2020
• 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