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

Model Number	V60
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2026
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 displayed a "backup alarm failed" error code (1104).The device was in clinical use when the issue was observed.No patient or user harm reported.The customer reported that during set up, the v60 ventilator displayed a "backup alarm failed" error code (1104).It was reported that the error code was confirmed, and the device was replaced.The device was evaluated by a service engineer (se), and it was reported that the issue was not duplicated at the repair center.The se reviewed the event log, and it was confirmed that the device had recorded a "check vent: backup alarm failed" error message (1104).The se noted that the central processing unit (cpu) needed to be replaced.The customer was provided with a quote for service.Investigation ongoing / resolution pending.
Additional Manufacturer Narrative
Based on the details provided, the device had malfunctioned, and the device had displayed the error code.The se reported that cpu board was replaced as a recurrence preventative measure.The software was updated to 3.20.The device was then checked, cleaned, and tested; the device was then returned to the customer, ready for service.A conclusion/root cause can not be provided at this time, as the suspected cpu board has not been returned for further analysis.In the event the suspected part is received, the evaluation will be performed, and the investigation will be updated.

• Brand Name: RESPIRONICS
• Common Device Name: VENTILATOR, CONTINUOUS USE, 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: 25114077
• Report Number: 2518422-2026-112968
• Device Sequence Number: 10272542
• Product Code: MNT
• UDI-Device Identifier: 00884838033832
• UDI-Public: (01)00884838033832(21)
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2026

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: 1076709
• 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: 04/21/2026
• Supplement Date Received by Manufacturer: 05/20/2026; 06/16/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 05/22/2026; 06/25/2026
• Date Device Manufactured: 05/23/2014
• 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