MAUDE Adverse Event Report: Respironics, Inc. Respironics; Ventilator, Continuous use, Minimal Ventilatory Support, Facility Use

Model Number	V60
Medical Device Problem Code	Unintended Power Up (1162)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A biomedical engineer (bme) reported that a v60 ventilator powered on by itself without patient involvement, resulting in no patient or user impact or harm.A philips remote service engineer (rse) assisted with troubleshooting, during which the uncommanded power-on issue was successfully replicated and confirmed.The rse mapped out the power switch electrical circuit path¿encompassing the power switch overlay, the user interface (ui) assembly printed circuit board assembly (pcba), and the power management (pm) pcba¿and advised the bme to isolate the system by disconnecting the battery.When tested strictly on alternating current (ac) power, the bme reported that the device no longer powered on by itself.The rse then instructed the bme to monitor the ventilator for several hours on ac power; if the issue does not recur, the battery should be replaced, but if the auto-power behavior returns, the bme must trace the previously discussed signal path.The bme was provided with the part number for a replacement battery, and the final investigation and disposition remain 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 ; +1(412)542-3300
• MDR Report Key: 50479711
• Report Number: 2518422-2026-115234
• Device Sequence Number: 10338737
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)00884838020054
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,Followup,Followup
• Report Date (Section B): 09/17/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2026
• Supplement Date Received by Manufacturer: Not provided; 09/02/2026; 09/15/2026
• Initial Report FDA Received Date: 08/27/2026
• Supplement Report FDA Received Date: 09/04/2026; 09/15/2026; 09/17/2026
• Date Device Manufactured: 01/24/2014
• 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