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

Model Number	V60
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint from the customer on the v60 ventilator indicating that a 1009 "pressure regulation high" error occurred.It is unknown if there was patient involvement at the time the issue was discovered; however, there was no report of patient or user harm.In accordance with the v60 service manual, the customer found that the data acquisition (da) printed circuit board assembly and motor controller (mc) pcba needed to be replaced after checking the pneumatic circuit.A quote consisting of the replacement parts was sent to the customer for approval.Repair of the device is currently pending.
Additional Manufacturer Narrative
A philips service engineer was not able to evaluate or repair the device as the customer ultimately did not accept the quote, and no work order was generated.No further information could be obtained regarding the reported device issue.The investigation concludes that no further action is required at this time.If the decision is made to have the device evaluated and repaired, a new service order will be opened and will be captured through philip's normal complaint procedure.If additional information becomes available at a later date, 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: 24447077
• Report Number: 2518422-2026-104617
• Device Sequence Number: 16063190
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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: 02/19/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/23/2026
• 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