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	06/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The serivce engineer (se) reported that the v60 ventilator had an enter button that was not responding.There was no patient involvement when the issue occurred.No patient impact and/or harm was reported.No user impact and/or harm was reported.No testing was reported to have been performed to determine the cause of the malfunction.The se was servicing the device when the issue was observed.The issue was replicated/confirmed during service.The se replaced the user interface (ui) board assembly to resolve the issue.No other abnormalities were found.The device was returned to the customer, ready for service.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.The se replaced the ui board assembly to resolve the issue.It is suspected that the cause of the malfunction was due to a failure in the ui assembly.A conclusion/root cause can not be provided at this time, as the suspected part has not been returned for further analysis.In the event the suspected part is received, the evaluation will be performed, and the investigation will be updated.Based on the details provided, a malfunction occurred, and the device's enter button was not responding.

• 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: 25612361
• Report Number: 2518422-2026-113971
• Device Sequence Number: 15945470
• 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): 06/24/2026

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: 1076709
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 06/24/2026
• Date Device Manufactured: 11/18/2018
• 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