MAUDE Adverse Event Report: Respironics, Inc. Respironics; Ventilator, Continuous, Minimal Ventilatory Support, Facility Use

Model Number	V60 V60Plus Ventilator
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the v60 ventilator displayed a "35v power supply fault" message.It was unknown how the issue was found.No patient impact and/or harm was reported.No user impact and/or harm was reported.It was reported that the v60 ventilator displayed a "35v power supply fault" message.No testing was reported to have been performed to replicate the issue and/or determine the cause.The issue was confirmed by the customer.No testing was reported to have been performed by the customer.It was reported that the driver board was replaced to resolve the issue.The customer reported that the device was returned to normal.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 details provided, a malfunction occurred, and the device displayed a "35v power supply failure" message.The cause of the malfunction was determined to be a failure in the driver board.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.
Additional Manufacturer Narrative
E1: reporting institution phone #: (b)(6).

• 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: 50931868
• Report Number: 2518422-2026-115482
• Device Sequence Number: 18532682
• Product Code: MNT
• UDI-Device Identifier: 00884838025776
• UDI-Public: (01)00884838025776
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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 V60Plus Ventilator
• Device Catalogue Number: 1076716
• 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: 09/22/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 04/02/2021
• 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