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

Model Number	V60
Medical Device Problem Code	Battery Problem: Low Impedance (2973)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E: (b)(6) medical center.
Event or Problem Description
Philips received a complaint by the customer on the v60 indicating that the battery was depleted.At this time, it is unknown if there was patient involvement at the time the issue was discovered; however, there was no reported harm to the patient or user.The customer called technical support to report that the battery was depleted.A service quote consisting of the replacement battery was sent to the customer for approval, and the customer accepted.Investigation is ongoing.
Additional Manufacturer Narrative
A field service engineer (fse) was dispatched onsite to evaluate and repair the device.Upon arrival, the fse replaced the internal battery, after which the issue was resolved.The device passed the required performance verification tests per philips standard and was returned to service.The investigation concludes that no further action is required at this time.If additional information is received, the complaint file will be reopened.
Additional Manufacturer Narrative
Per good faith effort (gfe) response, there was no patient involvement at the time the issue was discovered.No patient or user harm was reported.The battery (m72739p1, 20nov2017) was more than five years old and needed to be replaced, so the replacement of the battery is 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.A 1124 ¿battery failed¿ alarm error did not occur, and the device did not have a battery charging light emitting diode (led) error.

• 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: 23719932
• Report Number: 2518422-2025-058840
• Device Sequence Number: 10464283
• Product Code: MNT
• UDI-Device Identifier: 00884838009844
• UDI-Public: (01)00884838009844
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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,Followup
• Report Date (Section B): 01/27/2026

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: 11/12/2025
• Supplement Date Received by Manufacturer: 12/16/2025; 01/18/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/22/2025; 01/27/2026
• Date Device Manufactured: 11/17/2017
• 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