Quantum ® QDMURecalls & reported problems
Spectrum Medical Limited · Quantum Data Management Unit · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05060434420039), received between Sep 4, 2025 and Sep 4, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Intermittent Loss of Power” (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.
Reports received per month
Most reported problems
Device problems
- Intermittent Loss of Power3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 4, 2025Intermittent Loss of Power; Intermittent Loss of Power
USER REPORTED THAT THE UNIT LOSES POWER. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22964187 ↗MalfunctionSep 4, 2025Intermittent Loss of Power; Intermittent Loss of Power
USER REPORTED THAT THE UNIT LOSES POWER. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22964106 ↗MalfunctionSep 4, 2025Intermittent Loss of Power; Intermittent Loss of Power
USER REPORTED THAT THE UNIT LOSES POWER. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22964085 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.