N/A (REF 1859)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885825015831), received between Feb 21, 2018 and Feb 21, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Incorrect Measurement” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2018Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PULSE OXIMETER SENSOR GAVE INACCURATE READINGS. THE FACILITY REPORTED THAT ON A RELATIVELY SICK PATIENT, A PROCEDURE WAS ABORTED TO RESUSCITATE THE PATIENT FROM HYPOXIA WITH A TREMENDOUS A-A GRADIENT, INCLUDING THE USE OF ADVANCED TESTING LIKE BEDSIDE ECHO, INTRACARDIAC ECHO AND THE FACILITY WAS CONSIDERING ECHMO. IT WAS DETERMINED THE PATIENT WASN'T REALLY HYPOXIC. AFTER GETTING ABG RESULTS THAT CONFLICTED WITH THE DATA SEEN IN THE LAB, THE FACILITY SWITCHED THE PROBE, AND THE PATIENT¿S SATURATION WENT FROM 68% TO 100% IMMEDIATELY. THE PATIENT ENDED UP GOING INTUBATED TO THE ICU AFTER AN ABORTED PROCEDURE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN CLARITY AND ADDITIONAL INFORMATION FROM THE FACILITY. NO INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7287829 ↗