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

Model Number	V60 V60PLUS VENTILATOR
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Philips received a complaint by the customer on the v60 indicating that the unit suddenly shut down when the fio2 was set from 35% to 40%.The device was in use on a patient at the time of the reported issue was discovered; however, there was no harm to the patient or user.The device was swapped out with a different device.No medical intervention provided to the patient nor a delay was noted.It was reported that the unit suddenly shut down when the fio2 was set from 35% to 40%.It was also reported that a "check vent: ventilator restarted" appeared on the device and the device restarted during use on a patient.No alarms had occurred after the restart.The unit was sent to the repair center.At the repair center, the reported issue was not reproduced.The event log was checked, and it was confirmed that the history of "check vent: ventilator restarted." (diagnostic code 1101) and "user interface cpp." (diagnostic code 3007) had occurred together.It was then stated that if both error codes had occurred together then no further action is required.The device restarted to resolve the condition.The occurrence of "check vent: ventilator restarted." (diagnostic code 1101) and "user interface cpp." (diagnostic code 3007) together requires no action.A restart resolved the condition.The device passed required performance verification tests per philips standards and was returned 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.

• 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: 25535380
• Report Number: 2518422-2026-113614
• Device Sequence Number: 9616500
• 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,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 06/17/2026

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 V60PLUS VENTILATOR
• 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: 05/29/2026
• Initial Report FDA Received Date: 06/17/2026
• Date Device Manufactured: 02/06/2017
• 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: Unknown