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

Model Number	V60 V60Plus Ventilator
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the v60 ventilator displayed a "machine and proximal pressure sensors failed" error code (1007).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.The customer inquired about the part number for a replacement data acquisition (da) to motor controller (mc) cable; during the call, there was no allegation of malfunction reported.A follow up was performed with the customer, and it was reported that the device displayed a "machine and proximal pressure sensors failed" error code (1007).It was reported that the data acquisition (da) board, and gas delivery system (gds) were replaced for preventative maintenance; after replacement of the parts, the customer saw the error code.The customer attempted to replace the da to motor controller (mc) cable, but the issue was not resolved.The old da board was then reinstalled, and the issue was resolved.It was determined that the replacement da board was defective out of box (defoa).The issue was replicated/confirmed by the customer.The customer reported that the old da board was reinstalled to fix the issue.It was noted that the device was returned to service.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 "machine and proximal pressure sensors failed" error code (1007).The cause of the malfunction was determined to be a failure in the da board.A conclusion/root cause cannot 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.

• 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: 50805919
• Report Number: 2518422-2026-115438
• Device Sequence Number: 13414457
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)00884838020054
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: 09/01/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 01/04/2017
• 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