Quantum QVMRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05060434420688), received between Aug 26, 2022 and Oct 9, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Gas Output Problem” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2025Gas Output Problem; Gas Output Problem

  USER CONTACTED SPECTRUM BECAUSE OF A SIGNIFICANT VARIATION IN FIO2 AND SWEEP FLOW OBSERVED DURING THE CASE, AND A GAS OUTLET ALARM WAS NOTED. DEVICE WAS PUT ON THE SIDE FOR REVIEW. NO PATIENT HARM REPORTED AND NO IMPACT TO PATIENT SAFETY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23252656 ↗
• MalfunctionAug 6, 2025Suction Problem; Suction Problem

  USER REPORTED THAT WHILE USING THE VENTILATION MODULE DURING A CASE, THE VAVD WAS INACTIVE. THERE WAS NO VACUUM NOTED AT THE OUTLET. THERE WAS NO PATIENT HARM AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727831 ↗
• MalfunctionJul 22, 2025Gas Output Problem; Gas Output Problem

  USER REPORTED THAT THE QVM WAS NOT SHOWING PCO2 MEASUREMENT. THE USER TRIED SWITCHING OUT THE CABLES BUT THIS DID NOT RESOLVE THE ISSUE. THIS HAPPENED DURING SETUP. THE SUSPECTED FAULT WAS IMMEADIATLY OBVIOUS PRIOR TO USE, AND THERE WAS NO PATIENT HARM OR DELAY TO OPERATION AS A RESULT OF THIS ISSUE. THIS ISSUE WAS REPORTED TO ANSM BY THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563350 ↗
• MalfunctionJul 22, 2025Gas Output Problem; Gas Output Problem

  USER REPORTED THAT DURING THE CASE SWEEP DROPPED TO 2.9 L AND FIO2 DROPPED TO 21%. USER SWITCHED OUT THE QVM AS THEY WERE UNABLE TO CONTROL THE GAS WITH THE QVM. FOLLOWING THE CASE THE QVM WAS SUCCESSFULLY CALIBRATED WITH OUT IT RESOLVING THE ISSUE. WATER TRAPS WERE CHANGED AS MOISTURE WAS FOUND TOWARDS THE QVM SIDE. THERE WERE NO REPORTS OF LONG-TERM HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: Hypoxia

  MAUDE report 22563328 ↗
• MalfunctionApr 4, 2025Suction Problem; Suction Problem

  USER REPORTED THAT THEY WERE UNABLE USE VACUUM-ASSISTED VENOUS DRAINAGE (VAVD) DESPITE HAVING VACUUM INPUT. USER REPORTED THAT THEY COULD NOT FEEL VACUUM FROM VAVD PORT. MALFUNCTION OCCURRED DURING A CASE. THERE WAS NO PATIENT HARM. NO INTERRUPTION OF GAS FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21772775 ↗
• MalfunctionJan 31, 2025Suction Problem; Suction Problem

  THIS VMSR REPORT SUMMARIZES MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT MODEL QVM (PRODUCT CODE: 51-000045-00) EXPERIENCED AN ISSUE REGULATING VACCUM (EITHER VACUUM WAS NOT AVAILABLE, FLUCTUATED OR WAS INCORRECT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21282697 ↗
• MalfunctionDec 9, 2024Gas Output Problem; Gas Output Problem

  USER NOTICED FLUCTUATION IN MEASURED VALUES OF FIO2 AND PAO2 THAT DID NOT ALIGN WITH THE SETPOINT OF THESE VALUES. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878121 ↗
• MalfunctionDec 4, 2024Suction Problem; Suction Problem

  PERFUSIONIST REPORTED THAT THEY HAD DIFFICULTY RESETTING THE VACUUM TO NORMAL AFTER REAPPLYING THE CLAMP TO THE TUBING. THE DEVICE WAS CONTINUED TO BE USED TO COMPLETE THE CASE SUCCESSFULLY. WE CONSIDER INABILITY TO REGULATE VACUUM TO BE REPORTABLE, DESPITE NO HARM TO THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20840881 ↗
• MalfunctionNov 7, 2024Gas Output Problem; Gas Output Problem

  PERFUSIONIST UNABLE TO CONTROL GAS FLOW FOLLOWING AN ALARM ON QVM2. ANOTHER MEANS TO MANAGE THE GAS WAS USED. WE CONSIDER INABILITY TO CONTROL GAS FLOW TO BE REPORTABLE; HOWEVER, THE PATIENT WAS INVOLVED WITHOUT ANY CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20628554 ↗
• MalfunctionAug 26, 2022Suction Problem; Suction Problem

  IT WAS REPORTED THE VENTILATION MODULE WAS HAVING PROBLEMS WITH THE APPLIED VACUUM ISSUES THROUGH OUT THE WEEK DURING CASES. THEIR WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15299759 ↗