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

Model Number	V60
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint from the customer on the v60 ventilator indicating that a 1104 "backup alarm failed" alarm error occurred.It is unknown if there was patient involvement at the time the issue was discovered.There was no reported harm to the patient or user.A service quote was sent to the customer for approval.
Additional Manufacturer Narrative
A quote for onsite service was sent to the customer for approval, but the quote expired.A philips service engineer was not able to evaluate or repair the device as the customer ultimately did not accept the quote.No work order was generated, and it is therefore unknown what the outcome of the service event was.No further information could be obtained.The investigation concludes that no further action is required at this time.If additional information is received, a supplemental report will be submitted.
Additional Manufacturer Narrative
An authorized service engineer ultimately replaced the pm pcba for repair, after which the issue was resolved.After corrective maintenance, the device was operational and complied with the manufacturer's specifications.The necessary verifications were carried out to certify the restoration to the operating conditions prior to the failure.Based on the v60 service manual, the replacement pm pcba should resolve the issue.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: 24278716
• Report Number: 2518422-2026-100623
• Device Sequence Number: 18284938
• Product Code: MNT
• UDI-Device Identifier: 00884838009844
• UDI-Public: (01)00884838009844
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup
• Report Date (Section B): 04/29/2026

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: 01/29/2026
• Supplement Date Received by Manufacturer: 02/27/2026; 04/23/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/16/2026; 04/29/2026
• Date Device Manufactured: 07/12/2013
• 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