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

Model Number	V60
Medical Device Problem Code	Inadequate User Interface (2958)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported a v60 ventilator experienced a condition where the screen lock feature could not be unlocked by pressing the "enter" button.There was no patient involvement, harm, or injury reported at the time the issue was discovered.A philips authorized service provider (asp) evaluated the ventilator onsite and confirmed the reported failure before retrieving the device for depot-level service.During evaluation at the repair center, the reported failure mode could not be duplicated, and the device met all required engineering specifications.As a preventive measure to mitigate recurrence, the switch printed circuit board assembly (pcba) was replaced.Following the component replacement, the ventilator successfully passed all required performance verification tests per manufacturing standards and was returned to service.If /when components are received, an evaluation will be conducted and an additional report will be submitted.The data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.
Additional Manufacturer Narrative
E: (b)(6).

• 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: 25364251
• Report Number: 2518422-2026-113347
• Device Sequence Number: 13431842
• 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
• Report Date (Section B): 06/02/2026

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
• 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: 05/13/2026
• Initial Report FDA Received Date: 06/02/2026
• Date Device Manufactured: 02/12/2019
• 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