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

Model Number	V60 V60PLUS VENTILATOR
Medical Device Problem Code	Failure to Run on Battery (1466)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint by the customer on the v60 (software version 3.20) indicating a device malfunction as the device failed to power on and displayed a 1124 "battery failed" alarm error message.It was reported that there was no patient involvement at the time the issue was discovered.No patient or user harm was reported.The customer called technical support to report that the device failed to initialize and displayed a 1124 "battery failed" alarm error message.The device did not complete startup and entered a system restricted state, preventing the user to operate the device and perform preventive maintenance or functional testing.No accessories, including third-party devices, were being used that may have contributed to the issue.An authorized service provider (asp) was dispatched onsite to evaluate and repair the device, and upon arrival, the asp was able to replicate the issue after evaluating the error logs and verifying that the 1124 error code was logged.The asp deemed that the power management (pm) printed circuit board assembly (pcba) needed to be replaced according to the v60 service manual.Shortly after, another asp arrived onsite to service the device, and after installing the replacement pm pcba, the asp confirmed that the issue was resolved.The pm pcba replacement indicates that the cause of the malfunction was in fact due to a faulty pm pcba that needed to be replaced for repair.The investigation concludes that no further action is required at this time.

• 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: 25610756
• Report Number: 2518422-2026-113956
• Device Sequence Number: 9971757
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)00884838020054
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 06/24/2026

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 V60PLUS VENTILATOR
• Device Catalogue Number: 1053617
• 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: 06/05/2026
• Initial Report FDA Received Date: 06/24/2026
• Date Device Manufactured: 12/13/2018
• 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