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

Model Number	V60
Medical Device Problem Code	Unintended Power Up (1162)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Philips received a complaint from the customer, reporting that the v60 ventilator does not turn off.The device was in clinical use when the issue occurred.No patient or user harm reported.A philips remote service engineer (rse) noted that the customer's v60 ventilator does not turn off.A service engineer (se) evaluated the device and reported that the power supply and power management board were replaced.The se reported that additional repairs were required, as the device continues to turn on and off by itself.It was noted that a replacement user interface assembly was ordered.Investigation ongoing / resolution pending.
Additional Manufacturer Narrative
A follow up was performed with the service engineer (se), and it was reported that the power management board, and power supply did not resolve the issue.The user interface (ui) assembly was ordered in an attempt to resolve the issue.The replacement of the ui assembly is currently pending.
Additional Manufacturer Narrative
A service engineer (se) reported that the user interface (ui) assembly was replaced; however, the se did not specify if the issue was resolved, and that an additional follow up would need to be performed.Investigation remains ongoing.
Additional Manufacturer Narrative
Philips received a complaint from the customer, reporting that the v60 ventilator does not turn off.The device was in clinical use when the issue occurred.No patient or user harm reported.A follow up was performed with the service engineer (se), and it was reported that the power management board, and power supply did not resolve the issue.The user interface (ui) assembly was ordered in an attempt to resolve the issue.The replacement of the ui assembly is currently pending.A philips remote service engineer (rse) noted that the customer's v60 ventilator does not turn off.A service engineer (se) evaluated the device and reported that the power supply and power management board were replaced.The se reported that additional repairs were required, as the device continues to turn on and off by itself.It was noted that a replacement user interface assembly was ordered.A service engineer (se) reported that the user interface (ui) assembly was replaced; however, the se did not specify if the issue was resolved, and that an additional follow up would need to be performed.After the user interface (ui) assembly was replaced, the service engineer (se) noted that the system meets the specification for the performed service and is returned to use.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.
Additional Manufacturer Narrative
The returned user interface (ui) printed circuit assembly (pca) was evaluated by the product investigation lab (pil) to address the reported failure mode of "does not turn off." technicians installed the component onto a standard test bed (stb), where it successfully powered on, operated, and shut down normally without generating any error codes.A comprehensive review of the ventilator display and voltage measurements confirmed that all main power nodes were fully functional and well within engineering specifications.Additionally, the unit passed all required protocol testing across multiple power configurations, demonstrating normal power cycles using combined ac and battery power, battery power exclusively, and ac power exclusively.To check for intermittent faults or spontaneous behavior, the test unit was left in a powered-down state with power available for approximately 17 hours, during which it did not turn on by itself.Because the ui pca performed exactly as expected under all tested conditions, the investigation concluded with a determination of "no problem found," as the reported failure could not be replicated.

• 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: 21742946
• Report Number: 2518422-2025-040754
• Device Sequence Number: 4007581
• 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,Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/02/2026

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 04/01/2025; 05/06/2025; 05/09/2025; 05/26/2026
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 04/17/2025; 05/12/2025; 05/19/2025; 06/02/2026
• Date Device Manufactured: 12/07/2009
• 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