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

Model Number	V60
Medical Device Problem Code	Failure to Charge (1085)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint by the biomedical engineer (bme) on the v60 indicating that the device needed a battery and power cord following preventive maintenance (pm).There was no patient involvement at the time the issue was discovered.No patient or user harm was reported.The biomedical engineer (bme) called technical support to report that the device needed a battery and power cord following preventive maintenance (pm).The battery (2013) needed to be replaced as it was more than the recommended age 5 years old.The replacement of the battery would be aligned to the periodic maintenance procedure specified in the v60 service manual, which indicates that the battery requires replacement every 5 years to ensure proper system performance.Per the good faith effort (gfe) response received on june 3, 2026, the battery was not charging when the device was plugged in.When the bme powered on the device, the issue was confirmed as there was no power; the battery "¿ohmed out", and the power cord was faulty as something was broken on the inside of the power cord or plug.There were no exposed wires, and the device did not fail the electrical safety test.The bme ultimately placed an order for the replacement battery and power cord, but the parts have not arrived yet.The repair is still pending.

• 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: 25612968
• Report Number: 2518422-2026-113984
• Device Sequence Number: 16006962
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)00884838020054
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 06/29/2026

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: Other
• Device Model Number: V60
• 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: 06/03/2026
• Supplement Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 06/24/2026
• Supplement Report FDA Received Date: 06/29/2026
• Date Device Manufactured: 03/26/2013
• 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