Quantum QPR6Recalls & reported problems
Spectrum Medical Limited · Quantum Pressure Sensor Assembly - 2.0m · 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 05060434423306), received between Mar 26, 2026 and Mar 26, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Sense” (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
- Failure to Sense1
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.
MalfunctionMar 26, 2026Failure to Sense
DURING THE CASE, THE PRESSURE SENSOR USED FOR THE STOP AND MAX PRESSURE OF THE ARTERIAL PUMP STOPPED. THE PERFUSIONIST USED THE HAND CRANK UNTIL THE PRESSURE SENSOR WAS DEACTIVATED AND THE PUMP COULD BE STARTED. HAND CRANKING LASTED 2-3 MINUTES MAX. NO HARM OCCURRED FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24697128 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.