Quantum QVM2-N-HMRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05060434422064), received between Dec 5, 2024 and Feb 4, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (3 reports).

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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026No Visual Prompts/Feedback

  THE QUANTUM VENTILATION MODULE UNITS WERE FUNCTIONING AS EXPECTED; HOWEVER, WHEN THE LEVEL SENSOR WAS CONNECTED TO THE QVM, IT FAILED TO OPERATE PROPERLY. WHEN THE PROTECTED/SAFE LEVEL SAFETY WAS ENGAGED, THE LED ON THE LEVEL SENSOR DID NOT ILLUMINATE WHEN FLUID WAS PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256302 ↗
• MalfunctionFeb 3, 2026No Visual Prompts/Feedback

  THE QUANTUM VENTILATION MODULE UNITS WERE FUNCTIONING AS EXPECTED; HOWEVER, WHEN THE LEVEL SENSOR WAS CONNECTED TO THE QVM, IT FAILED TO OPERATE PROPERLY. WHEN THE PROTECTED/SAFE LEVEL SAFETY WAS ENGAGED, THE LED ON THE LEVEL SENSOR DID NOT ILLUMINATE WHEN FLUID WAS PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245712 ↗
• MalfunctionJan 27, 2026Output Problem

  CUSTOMER CONTACTED TO SAY THEY HAVE EXPERIENCED AN UNUSUAL EVENT DURING CASE. THE CUSTOMER STATED THAT THEY WENT ONTO BYPASS, ARTERIAL SAT ALARMING AT 90% AND THE QVM2 PO2 READING 55, THEY CLEANED THE PROBE AND CHECKED GAS ON EXTERNAL ANALYSER WHICH DISPLAYED 9. THEY THEN TURNED SWEEP UP 8-10LPM AND MENTIONED PCO2 = 6 AND PO2 = 40+. THEY HAVE RAN MAJORITY OF THE CASE WITH HIGH SWEEP VALVES AND NOTICED FLUCTUATIONS PCO2 AND PO2. THEY HAVE INCREASED THE SWEEP TO 15LPM AND THEN REPORTED THAT THE BLACK CAP ON THE CO2 PORT WAS BLOWN OFF THE QVM AND THEY WERE ABLE TO FEEL AIR EXITING IT. THEY HAVE MENTIONED PCO2 AND PO2 WAS INACCURATE. THEY HAVE ALSO EXPRESSED THAT THE WAG FLOW WAS INCORRECT, AT 15LPM SWEEP WAG FLOW WAS 10.4LPM. THERE WAS NO PATIENT HARM AND NO REPORTED DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24188319 ↗
• MalfunctionJan 27, 2026Output Problem

  CUSTOMER DID A BYPASS WITH FIO2 OF 60% AND NORMAL SWEEP. NO PHYSIOLOGIC ACTIVATED OR ANY AUTOREGULATION. PERFUSIONIST THOUGHT THAT BLOOD WAS DARK. BUT PO2 ON QWS SHOWED 500 MMHG, SO VERY HIGH. BLOODGAS SHOWED SHOWED A INITIAL PO2 OF 90 MMHG SO A VERY BIG DISCREPANCY. THEN RAISED THE FIO2, BUT THAT DIDNT SOLVE MUCH. SO DECIDED TO SWITCH TO EXTERNAL BACK UP GASBLENDER WITH Y CONNECTION (DUE TO DUAL CHAMBER). UPON QUERY ASKED SPECTRUM OXY WAS NOT ACTIVATED. ENGINEER ACTIVATED IT IN SETTINGS. CUSTOMER DECIDED TO GO BACK TO VENTILATION WITH QVM AND THEY FINISHED THE CASE WITHOUT DAMAGE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24188086 ↗
• MalfunctionDec 11, 2025Calibration Problem; Appropriate Device Problem Term/Code Not Available; Calibration Problem; Appropriate Device Problem Term/Code Not Available

  CUSTOMER HAS NOTICED THAT FECO2 IS UNDER-READING ON THE QVM2. THEY HAVE RECENTLY REPLACED WAG LINE FILTER, NOMOLINE AND FULL CIRCUIT AND STILL SEEING THE SAME ISSUE. PROTECTION OF THE WAG LINE IN GOOD- 2 FLUID TRAPS, 1 GAS LINE PROTECTOR CHANGED OUT REGULARLY, WHEN CONDENSATION IS SEEN, TUBING SYSTEM OPENED AND LEFT TO DRY OUT BETWEEN CASES. UNDERREADING PERSISTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23776762 ↗
• MalfunctionJun 20, 2025Under-Sensing; Under-Sensing

  USER REPORTED THAT THE THEIR FEC02 READING APPEARED TO BE UNDER READING SIGNIFICANTLY COMPARED TO THE OTHER SYSTEMS THAT WERE IN OPERATION AT THE TIME. NO ERRORS SEEN DURING THE CASE IN THE ALERTS TAB. THERE ARE TWO MOISTURE TRAPS. NO LEAKS IN THE WAG LINE AND SYSTEM WAS OBSERVED AND TROUBLESHOOTED BY A CLINICAL SPECIALIST. THERE WAS NO PATIENT HARM AS A RESULT OF THIS SUSPECTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22296728 ↗
• MalfunctionMay 20, 2025Under-Sensing; Under-Sensing

  USER REPORTED THAT THE THEIR FEC02 READING APPEARED TO BE UNDER READING SIGNIFICANTLY COMPARED TO THE OTHER SYSTEMS THAT WERE IN OPERATION AT THE TIME. NO ERRORS SEEN DURING THE CASE IN THE ALERTS TAB. THERE ARE TWO MOISTURE TRAPS. NO LEAKS IN THE WAG LINE AND SYSTEM WAS OBSERVED AND TROUBLESHOOTED BY A CLINICAL SPECIALIST. THERE WAS NO PATIENT HARM AS A RESULT OF THIS SUSPECTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22052752 ↗
• MalfunctionFeb 10, 2025Device Sensing Problem; Device Sensing Problem

  USER REPORTED THAT WHILE VENTILATION MODULE WAS AUTOMATICALLY REGULATING, THE GAS FLOW WENT TO ZERO. THE USER SWITCHED TO MANUAL MODE AFTER WHICH THE USER WAS ABLE TO GET RELIABLE VALUES. THERE WAS NO PATIENT HARM AS A RESULT OF THIS SUSPECTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21344256 ↗
• MalfunctionJan 30, 2025Suction Problem; Suction Problem

  DURING PREVENTATIVE MAINTENANCE, IT WAS FOUND THAT THE UNIT WAS NOT MAINTAINING A CONSTANT VAVD PRESSURE. WE CONSIDER THE INABILITY TO MAINTAIN A VACUUM TO BE REPORTABLE, DESPITE NO PATIENT INVOLVEMENT IN THIS INSTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21273062 ↗
• MalfunctionJan 9, 2025Suction Problem; Suction Problem

  USER REPORTED EXPERIENCING A FLUCTUATION OF VENOUS RETURN DUE TO VARIATION IN VAVD NEGATIVE PRESSURE. A PATIENT WAS INVOLVED BUT NOT HARMED. WE CONSIDERED IN ABILITY TO REGULATE PRESSURE A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112300 ↗
• MalfunctionDec 5, 2024Suction Problem; Suction Problem

  RESERVOIR PRESSURE SENSOR WAS REPORTING INCORRECT MEASUREMENTS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20853898 ↗