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	09/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint by a biomedical engineer (bme) on the v60 indicating a device malfunction as touchscreen calibration failed.There was no patient involvement at the time the issue was discovered as the issue occurred during preventive maintenance (pm).No patient or user harm was reported.Based on the case information provided, the device did not meet product specifications.The alleged malfunction impacted the user¿s ability to use the device properly.A biomedical engineer (bme) discovered that touchscreen calibration failed during preventive maintenance (pm) and found that the replacement touchscreen needed to be ordered.Upon receiving the replacement touchscreen, the bme replaced the defective touchscreen and performed the extended self-test (est), after which the issue was resolved.The touchscreen replacement indicates that the cause of the malfunction was ultimately due to a faulty touchscreen replacement that needed to be replaced for repair.The device passed the required performance verification tests per philips standard and was returned to service.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.

• 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 ; +1(724)733-0200
• MDR Report Key: 50884067
• Report Number: 2518422-2026-115468
• Device Sequence Number: 9939820
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)00884838020054
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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: User Facility
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: 1053617
• 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: 09/15/2026
• Initial Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 01/09/2019
• 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