Quantum QVM2-N-TMRecalls & reported problems
Spectrum Medical Limited · Quantum Ventilation Module - NIST (Tube Mount) · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05060434422743), received between Apr 10, 2026 and Apr 10, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Infusion or Flow Problem” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Infusion or Flow Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 10, 2026Infusion or Flow Problem
USER REPORTED A PROBLEM WITH THE VAVD, THE SETPOINT IS NOT HOLD AND COME BACK TO 0. SPECTRUM EMPLOYEE WENT ON SITE TO TEST UNIT. THE QVM DOES NOT HOLD THE SETPOINT AND SHOW ERROR 600.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24838563 ↗
Other Gas Control Unit, Cardiopulmonary Bypass devices
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- Quantum QVM2-D-HMSpectrum Medical Limited · Gas Control Unit, Cardiopulmonary Bypass36 reports
- Quantum QVM4-D-HMSpectrum Medical Limited · Gas Control Unit, Cardiopulmonary Bypass18 reports
- Quantum QVM2-N-HMSpectrum Medical Limited · Gas Control Unit, Cardiopulmonary Bypass11 reports
- Quantum QVMSpectrum Medical Limited · Gas Control Unit, Cardiopulmonary Bypass10 reports
- Quantum QLS1-200Spectrum Medical Limited · Gas Control Unit, Cardiopulmonary Bypass8 reports
- Electronic Gas Blender 5 l/minLivaNova Deutschland GmbH · Gas control unit, cardiopulmonary bypass5 reports
- Electronic Gas Blender 2 l/minLivaNova Deutschland GmbH · Gas control unit, cardiopulmonary bypass3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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