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

Model Number	V60 V60PLUS VENTILATOR
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 07may2026, philips received information from the affiliated hospital of guangdong medical university stating the following: a patient was admitted for treatment due to chronic obstructive pulmonary disease with acute exacerbation.On 29apr2026, the patient's blood oxygen saturation was 90% (hypoxemia), which was below the normal range.The nurses of the geriatrics department (intensive care unit) used a non-invasive ventilator as prescribed, strictly following the device manual to improve the patient's oxygenation and increase the patient's blood oxygen saturation to the normal range.After the device was powered on, it displayed a "no oxygen supply" error message.The operator checked the oxygen supply unit and oxygen connectors and confirmed that there were no abnormalities.The device still could not be used normally.The device was in use on the patient at the time the reported issue was discovered.Because the device malfunction was promptly detected and stopped in time, no substantial harm was caused to the patient; however, the patient was elderly, high-risk individual with severe underlying conditions, and there was a high safety risk during the device malfunction.After the failure occurred, the operator checked the oxygen device and oxygen connectors one by one.After confirming that there were no abnormalities, the device still could not operate normally.The head nurse was immediately notified, and a backup non-invasive ventilator was used to maintain the patient's ventilation.The patient's blood oxygen saturation stabilized at 98%, with no worsening of breathing difficulty; the patient's condition remained stable.The malfunctioning device was reported for repair to the medical equipment department.This investigation is ongoing.

• 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: 25242672
• Report Number: 2518422-2026-113120
• Device Sequence Number: 9725555
• 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,Followup
• Report Date (Section B): 06/08/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 06/08/2026
• Date Device Manufactured: 04/01/2021
• 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