OmniLab Advanced Plus OmniLab Advanced Plus, USRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00606959028791), received between Dec 29, 2022 and Jul 6, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (3 reports).

2 FDA recall records name this device's identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 26, 2022Open, Classified

   Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

   Z-1657-2022 · Root cause: Process control · FDA record ↗

2. Aug 26, 2022Open, Classified

   Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

   Z-1658-2022 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2026Electrical /Electronic Property Problem

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25719594 ↗
• MalfunctionMar 20, 2024Increase in Pressure; Increase in Pressure

  THE MANUFACTURER RECEIVED INFORMATION REGARDING AN OMNILAN ADVANCED PLUS. THE CUSTOMER ALLEGES THE DEVICE SEEMED TO BLOW HARDER THAN THE SETTING THE DEVICE WAS PLACED ON WHEN THE PATIENT BEGAN USE OF THE DEVICE. THE CUSTOMER ADJUSTED THE PRESSURE, THEN THE DEVICE ALARMED AND DISPLAYED A VENT INOPERABLE MESSAGE. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED FOR THE PATIENT. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THREE ATTEMPTS TO HAVE THE DEVICE RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18941747 ↗
• MalfunctionMar 8, 2024Unexpected Shutdown; Unexpected Shutdown

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18866500 ↗
• MalfunctionFeb 27, 2024Power Problem; Power Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CHECK AC POWER SUPPLY ERROR OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. PER THE CUSTOMER THEY TRIED A DIFFERENT OUTLET AFTER IT HAS ALARMED AND IT WORKED FINE. THE DEVICE DID HAVE ECG SPIKES, THE IMPEDANCE VALUES WERE RED AND COULD HAVE BEEN THE CAUSE FOR THE SPIKES IN THE HEART RATE CAUSING THE HIGH VALUES. THE BODY POSITION SENSOR WAS ALSO CAUSING INCORRECT READINGS. THE CUSTOMER INDICATED THAT THEY DID NOT SEE SENSORS ON THE BELTS. THEY WILL CHECK WITH OUTSIDE SALES TO SEE IF THEY WERE PROVIDED TO THEM. IF THEY HAVE FURTHER PROBLEMS THEY WILL CALL BACK. NO FURTHER ACTION IS NEEDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18794169 ↗
• MalfunctionFeb 27, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE CUSTOMER INFORMED THE TECH THAT THE DEVICE WAS ON A PATIENT WHEN THE VENT INOPERATIVE ALARMED. THEY RESTARTED THE DEVICE AND IT WORKED FINE AFTER THAT. THE TECH INFORMED THE CUSTOMER THE DEVICE WILL NEED SERVICED. PROVIDED THE NOTIFICATION NUMBER AND TRANSFERRED THE CUSTOMER TO REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18793927 ↗
• MalfunctionFeb 27, 2024Unexpected Shutdown; Unexpected Shutdown

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE DEVICE TURNS OFF. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER THEY WERE NOT ABLE TO CONFIRM CUSTOMERS COMPLAINT. THE DEVICE RAN OKAY AND PASSED THE TEST STAND. NO ERRORS FOUND IN ERROR LOG INDICATING FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18793926 ↗
• MalfunctionFeb 27, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE CUSTOMER INFORMED THE TECH THAT THE DEVICE WAS TURNED OFF AND THEN ON AGAIN AND THE ISSUE WENT AWAY. CUSTOMER WAS SENT THE NEWEST SOFTWARE VERSION FOR THE DEVICE. THE CUSTOMER INDICATED THEY WOULD GET THAT UPLOADED AND IF THEY HAVE ANY FURTHER ISSUE THEY WOULD CALL BACK. NO FURTHER ACTION WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18793924 ↗
• MalfunctionDec 29, 2022Degraded; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED TO COUGH. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THERE WAS NO MEDICAL INTERVENTION REQUIRED BY THE PATIENT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Cough

  MAUDE report 16068817 ↗