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

Model Number	V60
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by facility medical engineer a philips respironics v60 ventilator turned itself off and restarted unexpectedly while it was actively being used on a patient.A "restart" message appeared on the screen, and the device then went back to normal operation.The patient was quickly moved to a different ventilator.There was no delay in therapy, no medical intervention was needed, and no harm or injuries occurred.The hospital staff was blocked from using the machine, so they immediately removed it from service and sent it to be fixed.A service engineer tested the device but could not make the restart happen again on the test bench.However, when they checked the machine¿s internal computer history logs, they confirmed the malfunction happened.The computer logged two codes at the exact same time: code 1101 (which means the ventilator restarted because it hit a processing error) and code 3007.Code 1101 happens when the ventilator's main computer brain gets confused by unreadable data, a program glitch, or a software error.When this happens, the machine is designed to quickly restart itself to clear its memory and fix the problem.Normally, a code 1101 requires a technician to replace the main computer board and reinstall the software.However, the manufacturer's manual states that if code 1101 is paired with code 3007, it means the machine successfully fixed itself during the reboot.Therefore, no physical repairs were needed.Because the ventilator's built-in safety software successfully cleared the glitch and the machine passed all follow-up safety tests, the service center verified it was safe to use and returned it to the hospital ready for patients.
Additional Manufacturer Narrative
E: sansei medical equipment co., ltd.Fukushima supply center delivery destination 45-1 hachimanzuka, shimotoriwatari fukushima city fukushima prefecture 960-1106 japan phone: 024-544-2478.

• 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: 25233415
• Report Number: 2518422-2026-113100
• Device Sequence Number: 17452760
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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: 05/02/2026
• Initial Report FDA Received Date: 05/20/2026
• Date Device Manufactured: 08/22/2016
• 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