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	05/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
( b)(4).
Event or Problem Description
Philips received a complaint regarding a v60 ventilator describing a touchscreen calibration and alignment issue resulting in inaccurate and inconsistent touchscreen response during operation.It is unknown if the unit was in patient use at the time of the reported issue, and no patient or user harm was reported.The expected device behavior is a fully responsive and accurately calibrated touchscreen interface; however, the actual behavior observed and reported included persistent miscalibration, misalignment, and intermittent touchscreen responsiveness, which impacted the user¿s ability to reliably operate the device.The device was evaluated by philips field service engineer (fse) during onsite service activities.Troubleshooting included repeated recalibration attempts, functional assessment of the touchscreen under service and clinical modes, and diagnostic evaluation of system performance.These attempts did not restore normal operation, and the touchscreen failure was reproducible.Based on diagnostic findings, the touchscreen assembly was identified as the most likely failed component.The part was replaced, and electrical safety testing was performed as part of the service verification process.Post-replacement testing confirmed that normal touchscreen functionality was restored and the device met required performance specifications per philips service standards.The malfunction determination concluded that the device did not meet specification prior to repair due to failure of the touchscreen assembly, with the root cause identified as touchscreen hardware failure resulting in calibration instability and misalignment.This conclusion is supported by reproducible diagnostic failure, inability to correct the issue via recalibration, and successful restoration of function following component replacement.The overall conclusion of this investigation is that the touchscreen assembly failure caused the reported issue, which was resolved through replacement of the component, and the device is now functioning within specification.The complaint is considered closed unless new information becomes available that would require reopening of the investigation.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.

• 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: 25126975
• Report Number: 2518422-2026-112979
• Device Sequence Number: 10738069
• Product Code: MNT
• UDI-Device Identifier: 00884838009851
• UDI-Public: (01)00884838009851
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• 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: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1053614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Supplement Date Received by Manufacturer: 06/25/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2009
• 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