MAUDE Adverse Event Report: RESPIRONICS, INC. OMNILAB ADVANCED PLUS; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number	1109581
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging that, during a cpap titration study, the omnilab advanced plus flow generator (dom) generated alarms and displayed an inoperative message while in patient use.The reported issue has been identified under fsn 2023-cc-src-039 and is associated with interruptions and/or loss of therapy due to a ventilation inoperative alarm.The reporter indicated that, after several restart attempts, the device resumed operation without further alarming.The therapy pressure was observed to have changed from 6 cmh2o to 10 cmh2o.The caller requested guidance regarding continued use and was advised that the device should not be used until it had been assessed and verified with a manometer.No patient harm or injury was reported.The device has not been returned to the manufacturer for evaluation.Therefore, the root cause of the reported event cannot be determined at this time.If the device is returned for evaluation or additional relevant information becomes available, the manufacturer will investigate the event and submit a follow-up report, as appropriate.

• Brand Name: OMNILAB ADVANCED PLUS
• Common Device Name: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 25719594
• Report Number: 2518422-2026-030684
• Device Sequence Number: 18796529
• Product Code: MNS
• UDI-Device Identifier: 00606959028791
• UDI-Public: (01)00606959028791
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K121623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• 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
• Device Model Number: 1109581
• Device Catalogue Number: 1109581
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2014
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1817-2024
• Patient Sequence Number: 1
• Patient Sex: Unknown