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 Charge (1085)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: e1- (b)(6).
Event or Problem Description
Philips received a complaint by the customer on the v60 indicating that that the battery needed to be replaced as the device was not holding a charge during use.The device was in use on a patient at the time the reported issue was discovered; however, there was no reported harm to the patient or user.The customer called technical support to report that the battery needed to be replaced as the device was not holding a charge during use.A service quote consisting of the replacement battery was sent to the customer for approval, and the customer accepted.The investigation is ongoing.
Additional Manufacturer Narrative
The customer called technical support to report that the battery needed to be replaced as the device was not holding a charge during use.The battery is replaced every five years, which brings the customer to a deadline of 2025 for this device.A service quote consisting of the replacement battery was sent to the customer for approval, and the customer accepted.The replacement battery was ultimately ordered for repair.Per good faith effort (gfe) response, the event log could not be provided, but the observed message corresponded to a loss of battery charge; the battery lot number and serial number could not be provided, but the battery reached the end of its preventive life (5-year replacement cycle ¿ maturity 2025).The troubleshooting consisted of a functional analysis, confirming the loss of battery capacity.The problem was confirmed, and once the replacement battery was installed, the issue was resolved.The device passed the required performance verification tests per philips standard and was returned to service.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.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, 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: 23619573
• Report Number: 2518422-2025-054964
• Device Sequence Number: 10045386
• Product Code: MNT
• UDI-Device Identifier: 00884838009844
• UDI-Public: (01)00884838009844
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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: 1053613
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2012
• 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