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

Model Number	V60 V60PLUS VENTILATOR
Medical Device Problem Code	Inadequate User Interface (2958)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: reporting institution phone #: (b)(6).Reporter phone #: (b)(6).
Event or Problem Description
Philips received a complaint by a field service technician on the v60 indicating a device malfunction as there was a misalignment in the touch position.There was no patient involvement at the time the issue was discovered.No patient or user harm was reported.A field service technician performed regular maintenance on the device and confirmed that the touchscreen was not working as there was a misalignment in the touch position.The field service technician performed touchscreen calibration, but the issue remained.Therefore, the field service technician ultimately replaced the touchscreen, after which the issue was resolved.The touchscreen replacement indicates that the cause of the malfunction was due to a faulty touchscreen that needed to be replaced for repair.Following the touchscreen replacement, the field service technician confirmed that the software version was 3.20, conducted a comprehensive inspection of the device, cleaned the device, performed running and functional tests, and returned the device to service as it passed the required performance verification tests per philips standard.No other malfunction was found.The investigation concludes that no further action is required at this time.If additional information is received, the complaint file will be reopened.Based on the information provided and/or service performed, it was confirmed that the device did not meet product specifications.The alleged malfunction impacted the user¿s ability to use the device properly as the touchscreen was not working.

• 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: 25640541
• Report Number: 2518422-2026-114232
• Device Sequence Number: 18523221
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/26/2026

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 V60PLUS VENTILATOR
• Device Catalogue Number: 1076709
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 06/26/2026
• Date Device Manufactured: 01/10/2019
• 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