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	04/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Philips received a complaint on the v60 ventilator indicating that there was a pressure sensor autozero failed alarm.The device was reported to be in use at the time of the reported problem.No patient or user harm reported.A patient was admitted on (b)(6) 2026 with a diagnosis of chronic obstructive pulmonary disease (copd), accompanied by an acute lower respiratory tract infection, and with a history of "recuring coughing and expectoration accompanied by shortness of breath for over 20 years, with an exacerbation lasting more than half a month." on (b)(6) 2026, following a physician's orders, the assigned nurse initialed use of the non-invasive ventilation support with a v60 to treat the type 2 respiratory failure.Prior to use on the patient, a routine inspection of the non-invasive ventilator was conducted; the device appeared physically intact, its labeling was clear, and it remained within its valid service life.Upon powering on the device, the screen displayed a message: "ventilator not working, 1007: machine and proximal pressure sensor failure." the machine then alarmed for check vent: machine pressure sensor autozero failed.The event was reported to the head nurse, and a backup non-invasive ventilator was substituted.The replacement device passed its power-on self-test without issue and was placed into use.This investigation is ongoing.
Additional Manufacturer Narrative
A good faith effort (gfe) response was received from the authorized service provider (asp) on (b)(6) 2026.The asp did not provide the diagnostic report (drpt) from the time of the event.It was clarified that the device use at the time of the event was outside of use, prior to use on a patient.The asp stated that the customer hired a third party to repair the device.The repair work is still ongoing.

• 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: 25217418
• Report Number: 2518422-2026-113061
• Device Sequence Number: 10073369
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/04/2026

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: 05/12/2026
• Supplement Date Received by Manufacturer: 05/20/2026; 06/02/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 05/21/2026; 06/04/2026
• Date Device Manufactured: 02/03/2021
• 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