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	07/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 16sep2026, philips received a complaint from the second provincial general hospital of guangdong province on the v60 indicating a device malfunction as the device issued a "proximal pressure sensor autozero failed" alarm while the department was preparing to use this ventilator.It was reported that there was no patient involvement at the time the issue was discovered.No patient or user harm was reported.Normal operation resumed after the device was replaced.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.This investigation is ongoing.
Additional Manufacturer Narrative
E1: reporting institution phone #: (b)(6).Reporter 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: 50914316
• Report Number: 2518422-2026-115476
• Device Sequence Number: 5544683
• 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: User Facility
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 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: 09/16/2026
• Initial Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 11/06/2020
• 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