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 Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint by the customer on the v60 indicating while performing preventative maintenance (pm), it was observed that the device was getting error code 1111 check vent: oxygen device failed message, no measurement of oxygen o2.It was reported there was no patient involvement at the time the issue was discovered.The customer evaluated the device with the assistance of the remote service engineer (rse) and confirmed the reported problem.According to the maintenance findings, the device was observed to have no oxygen measurement, and the system displayed o2 error 1111.This indicates a failure within the oxygen sensing or delivery measurement pathway that requires further diagnostic evaluation.Diagnostics must be performed using the following test parts to determine the source of the malfunction using specific test parts.The rse informed customer that the components are required strictly for diagnostic testing and must not be unpacked until the malfunction is fully assessed.The rse provided the customer with additional troubleshooting steps for the repair per philips service manual.This investigation is ongoing.
Additional Manufacturer Narrative
E1: (b)(6).

• 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: 23645605
• Report Number: 2518422-2025-056639
• Device Sequence Number: 10107935
• Product Code: MNT
• Combination Product (Y/N): N
• 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: Foreign,User Facility
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2026

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: 1053613
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 09/09/2026
• Date Device Manufactured: 07/21/2020
• 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