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

Model Number	V60 V60PLUS VENTILATOR
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: reporting institution phone #: (b)(6).Reporter phone #: (b)(6).
Event or Problem Description
Philips received a complaint on the v60 ventilator indicating that there was an over-voltage protection (ovp) circuit failed alarm.The device was reported to be in use at the time of the reported problem.No patient or user harm reported.It was reported that a patient was suffering from respiratory failure and low blood oxygen saturation, so they required ventilator support via non-invasive ventilation.A nurse powered on the device to prepare the device for use, and it produced the ovp circuit failed alarm.The nurse immediately replaced the device with another non-invasive ventilator.In a good faith effort (gfe) response from the authorized service provider (asp), the alarm was clarified.The asp confirmed that service had been completed on the device by a third party service provider.The asp was only able to confirm that following the third party service, the device was returned to full functionality and was able to resume operation.The specific details of the repair were not provided by the customer.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.The product was determined to have malfunctioned.The likely cause of the issue cannot be determined due to the customers use a of a third party for service of the device.

• 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: 25460579
• Report Number: 2518422-2026-113552
• Device Sequence Number: 10449951
• Product Code: MNT
• UDI-Device Identifier: 00884838025776
• UDI-Public: (01)00884838025776
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/10/2026

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: 1076716
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 06/10/2026
• Date Device Manufactured: 08/14/2018
• 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