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

Model Number	V60
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint by the customer on the v60 indicating that the device is getting an error oxygen disconnected even though it is connected.The device was in use on a patient at the time the reported issue was discovered; however, there was no harm to the patient or user.No medical intervention provided to the patient, nor a delay was noted.The customer evaluated the device with the assistance of the remote service engineer (rse) and confirmed the reported problem.The rse instructed the customer to run some tests to verify that the oxygen connections were properly tightened.After the customer performed the suggested tests and adjusted connections, the customer informed that it resolved the reported issue.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
(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: 22545691
• Report Number: 2518422-2025-048248
• Device Sequence Number: 15635056
• Product Code: MNT
• UDI-Device Identifier: 00884838009868
• UDI-Public: (01)00884838009868
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/18/2025

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 07/18/2025
• Date Device Manufactured: 07/13/2015
• 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