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

Model Number	V60
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint from the customer on the v60 ventilator indicating that the alarms do not function.It is unknown if the unit was in patient use at the time of the reported issue.There was no patient or user harm reported.
Additional Manufacturer Narrative
It was reported there was no patient involvement at the time the issue was discovered.A service quote was approved by the customer.A philips authorized service provider (asp) went on-site and determined that a replacement of the display assembly and speaker was required.Device repair is still pending.
Additional Manufacturer Narrative
A philips asp replaced the user interface (ui) assembly and speaker to resolve the reported issue.The device passed required performance verification tests per philips standards and was returned to service.
Additional Manufacturer Narrative
The removed speaker was returned to the product investigation lab (pil).The speaker was temporarily installed on the standard test bed (stb), and it was noted there was an alarm for "check vent: primary alarm failed".It was also verified that the speaker failed pin to pin and solder to solder joint testing.It was confirmed the failure of this returned speaker was due to an open resistance to the voice coil of the speaker.Pil confirmed the removed speaker is faulty.

• 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 ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 21472817
• Report Number: 2518422-2025-023355
• Device Sequence Number: 21020137
• Product Code: MNT
• UDI-Device Identifier: 00884838009868
• UDI-Public: (01)00884838009868
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup
• Report Date (Section B): 03/12/2026

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
• Device Catalogue Number: 1053615
• 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: 02/18/2025
• Supplement Date Received by Manufacturer: 03/07/2025; 05/06/2025; 03/11/2026
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 03/13/2025; 05/13/2025; 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2011
• 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