Quantum ® System M ® HBS4-200Recalls & reported problems
Spectrum Medical Limited · Hb / SO2 Twin - Tube ID 3/8" x Wall 3/32" (OD 9/16") 2m · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05060434420602), received between Sep 10, 2024 and Apr 16, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (2 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. 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
- Incorrect Measurement2
- Electrical /Electronic Property Problem1
- Failure to Sense1
- Incorrect, Inadequate or Imprecise Result or Readings1
- Sensing Intermittently1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 16, 2026Incorrect Measurement
USER REPORTED INACCURATE READINGS FROM SAT/CRIT SENSORS, WHICH COULD RESULT IN CLINICAL MISMANAGEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24896444 ↗MalfunctionMar 13, 2026Incorrect Measurement
USER REPORTED THAT THE SATURATION VALUE WAS INCORRECTLY MEASURED, BUT SYSTEM DID NOT DETECT AN ISSUE. THE USER KNEW TO RESET THE SENSOR TO RESOLVE THE ISSUE, SO THERE WAS NO PATIENT HARM; HOWEVER, RECURRENCE OF THE PROBLEM COULD RESULT IN PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24589826 ↗MalfunctionJan 15, 2026Incorrect, Inadequate or Imprecise Result or Readings
USER REPORTED THAT DESPITE CALIBRATION, THE SENSOR VALUES WERE SLIGHTLY MISMEASURED. THERE WAS NO PATIENT HARM; HOWEVER, SPECTRUM MEDICAL CONSIDERS THIS EVENT TO BE REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24082769 ↗MalfunctionOct 20, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
A SAT/HGB PROBE WAS REPORTED AS DISPLAYING!!! FOR SAO2 AND HGB READINGS. THE CLINICAL TEAM PERFORMED A HARD REBOOT OF THE PROBE AND TRIED IT ON A SUBSEQUENT CASE WITH THE SAME RESULT. UNFORTUNATELY, THIS IS BEING REPORTED A WEEK AFTER THE FACT AND THE CLINICAL TEAM IS NOT SURE WHICH QWS THIS OCCURRED ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23334652 ↗MalfunctionOct 17, 2025Sensing Intermittently; Sensing Intermittently
THE PERFUSIONIST CALLED TODAY TO INFORM THAT DURING A CASE YESTERDAY THE SENSOR WORKED INTERMITTENTLY. THIS MORNING IT STARTED BY WORKING NORMALLY THEN STOPPED. THEY RESTARTED THE UNIT, CHANGED LOCATION OF THE SENSOR, CHECKED FOR IRREGULARITIES BUT IT WAS NOT GOING ON AGAIN. NO VISIBLE DAMAGE IS SEEN ON THE SENSOR, NO CHANGE IN THE USUAL CONSUMABLES, LIGHT ON BOTH HEADS OF THE SENSOR STILL FLASHING. NO PATIENT HARM REPORTED AND NO IMPACT TO PATIENT SAFETY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23323567 ↗MalfunctionSep 10, 2024Failure to Sense; Failure to Sense
USER REPORTED THAT THEIR SAO2 WAS READING 0 FOR 70% OF THE CASE. THE USER TRIED FACTORY RESETTING THE VALUE BUT WERE CONTINUOUSLY UNSUCCESSFUL RECALIBRATING. THE USER REPORTED THAT THIS WAS AFFECTING THE PAO2 READING FOR THE ENTIRE CASE. AT THE END OF THE CASE THE VALUE SPIKED AT 99 BEFORE WORKING CORRECTLY FOR THE VERY END OF THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20180948 ↗
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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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