Quantum QVM4-N-HMRecalls & reported problems
Spectrum Medical Limited · Quantum ECLS Ventilation Module - NIST (Hook Mount) · Class 2
- 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 05060434422842), received between Feb 10, 2025 and Feb 10, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Output 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
- Output 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.
MalfunctionFeb 10, 2025Output Problem; Output Problem
USER REPORTED THAT DURING ECLS TREATMENT, THEY EXPERIENCED PHASES WITH UNEXPECTED VERY LOW AND VERY HIGH PCO2 VALUES BETWEEN 4-180MM/HG. DURING THE CASE THE USER ALSO REPORTED REPLACING MASIMO DISPOSABLE 2 TIMES DUE TO VISIBLE CONDENSATION. THERE WAS NO PATIENT HARM AS A REULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21344254 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.