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

Model Number	V60
Medical Device Problem Code	Display Difficult to Read (1181)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint from the customer, reporting that the v60 ventilator had a dim display.There was no patient involvement when the issue occurred.No patient or user harm reported.The philips remote service engineer (rse) informed the customer to update the display or replace the user interface (ui) assembly.The customer was provided with the part number for a replacement ui assembly.The customer reached back out to the service engineer and requested on-site service.
Additional Manufacturer Narrative
Insufficient information is available to determine the resolution of the event.The customer was provided with a quote for onsite service; however, the quote expired, and the record was closed with no further actions performed by philips.No further details could be obtained regarding the event, and it could not be determined if the customer's issue was resolved or if the device had been repaired.No parts were returned for failure investigation.In the event that parts are returned or if new information is provided, the complaint will be reopened to update the investigation.

• 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: 20837104
• Report Number: 2518422-2024-072941
• Device Sequence Number: 4058400
• Product Code: MNT
• UDI-Device Identifier: 00884838020047
• UDI-Public: (01)00884838020047
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2025

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: Other
• Device Model Number: V60
• Device Catalogue Number: 1053616
• 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: 11/18/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 01/13/2025
• Date Device Manufactured: 08/03/2010
• 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