MAUDE Adverse Event Report: RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, 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	12/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on the v60 ventilator indicating that the power cord was good, but the indicator light emitting diode (led) on the front panel wasn't showing when plugged in.The customer informed the remote service engineer (rse) that the battery wasn't charging, and the power indicator light wasn't on when plugged into power.The device was reported to be outside of use at the time of the reported problem.There was no patient or user harm reported.The customer informed the remote service engineer (rse) that the battery wasn't charging, and the power indicator light wasn't on when plugged into power.The customer checked the power at the j1 connector of the power management (pm) printed circuit board assembly (pcba) and found the 24-volt direct current (dc) to be good.The customer reconnected the connector to the j1 and reconnected alternating current (ac) power.The customer now observed the amber led was illuminated and the battery led was steady.The device powered on into diagnostic mode and the customer verified that all the voltages showed as good in the pneumatics screen with the battery showing 16.5 volts dc, fully charged.The customer was advised by the rse to monitor the device, cycling the power on and off and disconnecting and reconnecting ac power.The customer was advised that if the problem returns to the 24-volt dc again, replace the pm pcba.
Additional Manufacturer Narrative
Multiple good faith efforts (gfe) were attempted to obtain confirmation of a part order, part replacement, and resolution.No response or further information was received from the customer.Philips is unable to confirm the final disposition of the device.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened and a supplemental report will be submitted.

• 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: 23881954
• Report Number: 2518422-2025-059073
• Device Sequence Number: 9464305
• Product Code: MNT
• UDI-Device Identifier: 00884838020047
• UDI-Public: (01)00884838020047
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/06/2026

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: 1053616
• 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: 12/05/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 01/06/2026
• Date Device Manufactured: 02/10/2011
• 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