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	03/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E: (b)(6).Reporter phone: (b)(6).
Event or Problem Description
Philips technical support received a complaint by the customer on the v60 indicating that the device turned on and off by itself.The device was in use on a patient at the time the reported issue was discovered; however, there was no reported harm to the patient or user.Additional information is being gathered.
Additional Manufacturer Narrative
Multiple attempts have been made to try to obtain further case information regarding the issue, evaluation, and repair; however, no response was received, and the malfunction could not be confirmed.It is therefore unknown what the outcome of the reported issue was, and no further information could be obtained.The investigation concludes that no further action is required at this time.This file is closed and can be reopened if new information becomes available.

• 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: 24884782
• Report Number: 2518422-2026-112227
• Device Sequence Number: 18782705
• Product Code: MNT
• UDI-Device Identifier: 00884838009844
• UDI-Public: (01)00884838009844
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2026

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: 1053613
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 05/01/2026
• Date Device Manufactured: 04/18/2017
• 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