MAUDE Adverse Event Report: RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number	V60 V60PLUS VENTILATOR
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint by the customer on the v60 indicating that the display was dark.It was reported there was no patient involvement at the time the issue was discovered.It was reported that the display was dark.It was also stated that only the alarm light emitting diode (led) was lit even after the unit as powered on during in an inspection.It was suspected that the cause of the issue was due to the hospital's outlet due to the device being able to be used in other rooms.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: 25635636
• Report Number: 2518422-2026-114209
• Device Sequence Number: 9836854
• Product Code: MNT
• UDI-Device Identifier: 00884838033832
• UDI-Public: (01)00884838033832
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 06/26/2026

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: 1076709
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 06/26/2026
• Date Device Manufactured: 02/13/2018
• 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