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

Model Number	V60
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint from the technician, reporting that the v60 ventilator displayed a "pb autozero of the internal pressure sensor" error code.There was no patient involvement when the issue occurred.No patient or user harm reported.The technician noted that the v60 ventilator displayed a "pb autozero of the internal pressure sensor" error code, while in normal ventilation mode.The technician also reported that the pressure accuracy was out of range, as the machine zero offset is between 1 and -1.5, but the value was 1.52.Troubleshooting was performed, and it was reported that the message did not reappear after another try.The service engineer (se) recommended checking the positioning of the data acquisition (da) card and checking the proximal and machine tubing.The se also recommended replacing the da card.A quote was provided to the customer.Investigation ongoing / resolution pending a review of the risk management file was performed, and it was determined that this complaint is a reportable malfunction.Regulatory reports have been/will be submitted per regulations.
Additional Manufacturer Narrative
E: (b)(6).Institution phone: (b)(6).Reporter phone: (b)(6).
Additional Manufacturer Narrative
Insufficient information was available to determine the resolution of the event.A replacement da card was shipped to the customer; however, after multiple good faith efforts (gfe) were performed for further details, no response was provided.No further details could be obtained regarding the event, and it could not be determined if the customer's issue was resolved or if the device had been repaired.The final disposition of the device could not be determined.This record is subject to reopening and supplemental submission should additional information becomes available.

• 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: 24806052
• Report Number: 2518422-2026-111976
• Device Sequence Number: 9944319
• Product Code: MNT
• UDI-Device Identifier: 00884838009868
• UDI-Public: (01)00884838009868
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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: Other
• Device Model Number: V60
• Device Catalogue Number: 1053615
• 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: 03/30/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 05/22/2026
• Date Device Manufactured: 05/03/2012
• 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