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	05/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on the v60 ventilator indicating that there was an over-voltage protection (ovp) circuit failure.No patient or user harm reported.The device was reported to be in use at the time of the reported problem.A patient was admitted with a diagnosis of acute upper respiratory tract infection.The patient was placed on the ventilator, and it initially operated normally.However, during a subsequent round by a nurse it was discovered that the device was displaying the ovp circuit failure alarm.The patient's breathing rhythm was observed to be desynchronized with the ventilators air delivery rhythm.This investigation is ongoing.
Additional Manufacturer Narrative
(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 ; 7247330200
• MDR Report Key: 25374445
• Report Number: 2518422-2026-113406
• Device Sequence Number: 10551872
• 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
• Report Date (Section B): 06/09/2026

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: 05/25/2026
• Supplement Date Received by Manufacturer: 06/07/2026
• Initial Report FDA Received Date: 06/03/2026
• Supplement Report FDA Received Date: 06/09/2026
• Date Device Manufactured: 08/15/2020
• 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