RD SET 4003Recalls & reported problems
Masimo Corporation · RD SET Neo SpO2, PR, PI, PVI Neonatal/Adult Pulse Oximeter Adhesive Sensor · 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 00843997009591), received between Jun 14, 2024 and Jun 14, 2024 — classified as 1 malfunction.
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
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.
MalfunctionJun 14, 2024
PULSE OXIMETER NEW FROM PACKAGE, DID NOT READ. TROUBLESHOOTED MONITOR AND CABLES, DETERMINED TO BE PULSE OX AS PRIOR PULSE OX WAS READING. MONITOR READ WITH NEW PULSE OX. MANUFACTURER RESPONSE FOR OXIMETER, RD SET (PER SITE REPORTER).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19537153 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.