Quantum ® System M ® HBS1-200Recalls & reported problems
Spectrum Medical Limited · Hb / SO2 Twin - Tube ID 3/16" x Wall 1/16" (OD 5/16") 2m · 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 05060434420633), received between Nov 5, 2025 and Nov 5, 2025 — classified as 1 malfunction.
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
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.
MalfunctionNov 5, 2025Device Sensing Problem; Device Sensing Problem
USER REPORTED THAT THE SAT CRIT SENSOR WAS PROVIDING INCORRECT MEASUREMENTS REGARDLESS OF FACTORY RESET. SPECTRUM MEDICAL CONSIDERS THIS TO BE REPORTABLE, BUT THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23478688 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.