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

Model Number	V60
Medical Device Problem Code	Failure to Run on Battery (1466)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint by the authorized service provider (asp) on the v60 indicating that a 1124 "battery failed" alarm error occurred.There was no patient involvement at the time the issue was discovered.No patient or user harm was reported.The authorized service provider (asp) evaluated the device, found that a 1124 "battery failed" alarm error was logged in the event log, and discovered that the power management (pm) printed circuit board assembly (pcba) needed to be replaced for repair.A quote consisting of the replacement pm pcba was sent to the customer for approval.Resolution and disposition:.
Additional Manufacturer Narrative
(b)(6).
Additional Manufacturer Narrative
The asp ultimately replaced the pm pcba for repair, after which the issue was resolved.After corrective maintenance, the device was operational and complied with the manufacturer's specifications.The necessary verifications were carried out to certify the restoration to the operating conditions prior to the failure.Based on the v60 service manual, the replacement pm pcba should resolve the issue.The investigation concludes that no further action is required at this time.If additional information is received, the complaint file will be reopened.

• 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: 24595106
• Report Number: 2518422-2026-109496
• Device Sequence Number: 21140661
• Product Code: MNT
• UDI-Device Identifier: 00884838009844
• UDI-Public: (01)00884838009844
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2026

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: 1053613
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: 05/23/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/30/2026
• Date Device Manufactured: 07/12/2013
• 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