03 Sensor rS02 Large Adhesive Sensor 3756Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10843997008416), received between Mar 21, 2017 and Sep 1, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Defective Alarm” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Defective Alarm; Display or Visual Feedback Problem; Incorrect, Inadequate or Imprecise Result or Readings

  The customer reported that they did not receive accurate O3 readings during the procedure, and no error message was displayed. The readings froze after approximately 60 minutes of monitoring. The customer unplugged and reconnected the sensors, after which they resumed measuring correctly. There was no patient impact or consequence reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50535906 ↗
• InjuryMar 21, 2017Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE O3 SENSOR EMITTERS AND DETECTOR ARE TOO ROUNDED, AND PROTRUDE FAR ENOUGH OUT THAT CAUSES SKIN INDENTATIONS, THE ATTACHED PICTURES ARE EXAMPLES OF 20 SECONDS OF LIGHT PRESSURE APPLIED EVENLY ON THE SENSOR. THIS WAS NOTED BY US, NO CUSTOMER COMPLAINT FROM THE ATTACHED PICTURE. I DON¿T HAVE PICTURES OF THE ACTUAL PATIENT SKIN, HOWEVER, THE CUSTOMER COMPLAINED THAT THIS WILL BE AN ISSUE FOR HIS PATIENTS. THERE WAS NO REFERENCE MADE OR INFORMATION GIVEN BY THE CUSTOMER, ON WHICH SPECIFIC PATIENT THIS HAPPENED. WE COULDN¿T FOLLOW UP. PICTURE ATTACHED IS FROM ANOTHER PATIENT, WHERE NO COMPLAINT WAS MADE, BUT WE NOTICED INDENTATIONS LEFT ON THE SKIN. HIS CONCERN WAS SPECIFICALLY FOR PRONE PATIENTS AND FOR BEACH CHAIR APPLICATIONS, WHERE THE FOREHEAD IS STRAPPED AND PINNED AGAINST THE BACK CUSHION FOR STABILITY. SAME THING ON THE PRONE PATIENTS. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6420754 ↗