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

Model Number	V60
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The occurrence error codes for, "check vent: oxygen device failed" (diagnostic code 1111) and "oxygen not available" (diagnostic code 1208) were observed in the event log therefore a functional test as well as an inspection of the oxygen device was performed.The repair center personnel stated that there were moments where the flow exceeded the leak compensation capability temporarily by opening the circuit which caused the occurrence of the error codes but no device malfunction.The repair center personnel then confirmed there was no malfunction found.The repair center personnel were unable to reproduce the reported issue.The device passed required performance verification tests by philips standards and was returned to service.
Event or Problem Description
Philips received a complaint from the customer on the v60 ventilator indicating that an "oxygen not available" alarm occurred.It was noted that the device kept operating when the issue was observed.The device was in use on a patient at the time the reported issue was discovered; however, there was no harm to the patient or user.The device was swapped out with a different device.There was neither delay in therapy nor medical intervention reported due to the issue other than the ventilator swap.There was no report of patient or user harm.It was documented that the device was run in the medical engineer center, but the reported issue was not reproduced.The investigation is ongoing.

• 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: 25059359
• Report Number: 2518422-2026-112831
• Device Sequence Number: 9400026
• Product Code: MNT
• UDI-Device Identifier: 00884838033832
• UDI-Public: (01)00884838033832
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/08/2026

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: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1076709
• 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: 04/23/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 05/08/2026
• Date Device Manufactured: 08/03/2017
• 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: Female