Quantum ® QDM1Recalls & reported problems
Spectrum Medical Limited · Quantum Diagnostic Module · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05060434420701), received between Jul 5, 2024 and Feb 4, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device Sensing 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Sensing Problem1
- Energy Output Problem1
- High Readings1
- Incomplete or Inadequate Connection1
- Output Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Low Oxygen Saturation1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 4, 2026Energy Output Problem; Output Problem
THIS ISSUE RELATES TO INACCURATE SWEEP FLOW, WHICH IS ONLY DISPLAYING ROUGHLY HALF OF THE VALUE SET BY THE GAS BLENDER. THERE WAS NO PATIENT HARM AND NO DELAY TO OPERATION. THIS DEVICE IS BEING RETURNED FOR CALIBRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24256539 ↗MalfunctionAug 26, 2025High Readings; High Readings
USER REPORTED THAT WHEN CHECKING THE GAS FLOW ACCURACY, THE READING VALUE WAS NOT WITHIN ALLOWABLE TOLERANCES. READING VALUE FOR FLOW RATE IS 7.1LPM RATHER THAT THE EXPECTED 5LPM. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22894581 ↗MalfunctionJan 31, 2025Device Sensing Problem; Device Sensing Problem
USER REPORTED ISSUES RELATED TO DEVICE SENSING PROBLEMS USING SENSORS. INABILITY TO CORRECTLY SENSE IS CONSIDERED A REPORTABLE EVENT. THERE WAS NO PATIENT HARM AS A RESULT OF THESE MALFUNCTIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21282751 ↗MalfunctionJul 5, 2024Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
USER REPORTED THAT THEY NOTICED DARK ARTERIAL BLOOD AND LOW SVO2 ON INITIAL OF BYPASS WHILST MANUAL GAS BLENDER 02 SWEEP WAS SET AT 2L AND FIO2 SET AT 100%. THE PATIENT WAS WEANED OFF BYPASS TO ALLOW FOR REOXYGENATION VIA THE VENTILATOR AND TO HAVE TIME TO TROUBLE SHOOT THE GAS ISSUE. ON INSPECTION, THE USER REPORTED THAT THEY NOTICED THAT THE GAS SUPPLY FROM MANUAL GAS BLENDER TO QDM WAS NOT COMPLETE ON THE QDM. THE GAS CIRCUIT WAS RECONNECTED, AND BYPASS WAS RE-INITIATED WITHOUT FURTHER ISSUES.
Patient problems: Low Oxygen Saturation
MAUDE report 19679460 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.