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

Model Number	V60
Medical Device Problem Code	Tidal Volume Fluctuations (1634)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a customer complaint regarding a v60 ventilator malfunction where the device failed to sense any patient volumes.At the time of the event, the device was actively in use on a patient, but no harm to the patient or user was reported.The device was promptly taken out of service, and the customer contacted technical support to report the volume sensing issue.The user encountered no error codes or error messages during the event, and no accessories or third-party devices contributed to the problem.A remote service engineer (rse) performed troubleshooting with the customer and confirmed the issue.Because the device was under contract, the customer requested onsite service.In response, the rse provided the customer with a bench repair document and created a work order to dispatch an authorized service provider (asp) to evaluate and repair the machine onsite.Upon arriving onsite, the asp replicated the reported issue as soon as they powered on the device, observing that the screen failed to show proper data values and instead displayed only asterisks.To troubleshoot, the asp attached a lung testing kit and confirmed that the device was not reading any volume values.The asp then checked all internal tubing and cycled the device's power, but the issue remained unresolved.Ultimately, the asp replaced the blower assembly and the gas delivery subsystem (gds).Following these replacements, the asp performed all required testing according to the v60 service manual and verified that the issue was resolved.The device successfully displayed proper values, passed its test and verification protocols, and was safely returned to service.The need to replace the blower assembly and the gds indicates that the root cause of the malfunction was a faulty blower and a defective gas delivery system.The investigation concludes that no further action is required at this time, and the complaint file will be reopened if any additional information is received.

• 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 ; 4125423300
• MDR Report Key: 25724913
• Report Number: 2518422-2026-114439
• Device Sequence Number: 9385580
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)00884838020054
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 07/06/2026

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: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1053617
• 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: 06/18/2026
• Initial Report FDA Received Date: 07/06/2026
• Date Device Manufactured: 06/06/2016
• 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