O3 4384Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10843997013496), received between Jun 8, 2021 and Mar 16, 2023 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE CUSTOMER REPORTED THE "NEAR-INFRARED SPECTROSCOPY (NIRS) PROBE ON RIGHT LOWER BACK RESULTED IN TWO SUPERFICIAL SKIN TEARS." THERE WERE NO ADDITIONAL MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 16560108 ↗
• MalfunctionMar 16, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE CUSTOMER REPORTED THE "NEAR-INFRARED SPECTROSCOPY (NIRS) PROBE ON LOWER BACK RESULTED IN A MEDICAL ADHESIVE RELATED SKIN INJURY (MARSI) WITH PARTIAL THICKNESS." THERE WERE NO ADDITIONAL MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 16560053 ↗
• MalfunctionMar 16, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE CUSTOMER REPORTED THE "NEAR-INFRARED SPECTROSCOPY (NIRS) PROBE ON MID BACK (SPINE) RESULTED IN A MEDICAL ADHESIVE RELATED SKIN INJURY (MARSI) WITH PARTIAL THICKNESS." THERE WERE NO ADDITIONAL MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 16554759 ↗
• MalfunctionMar 16, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE CUSTOMER REPORTED THE "NEAR-INFRARED SPECTROSCOPY (NIRS) PROBE ON LEFT LOWER BACK RESULTED IN A MEDICAL ADHESIVE RELATED SKIN INJURY (MARSI) WITH PARTIAL THICKNESS." THERE WERE NO ADDITIONAL MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 16554744 ↗
• MalfunctionMar 14, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE CUSTOMER REPORTED THE "NIRS PROBE ON RIGHT FOREHEAD RESULTED IN A LESION WITH PURPLE DISCOLORATION." NO ADDITIONAL MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 16539774 ↗
• MalfunctionMar 10, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE CUSTOMER REPORTED "NEAR-INFRARED SPECTROSCOPY (NIRS) PROBE ON THE RIGHT FLANK RESULTED IN A STAGE 1 PRESSURE ULCER/INJURY." NO ADDITIONAL MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 16526983 ↗
• MalfunctionMar 4, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE CUSTOMER REPORTED THE "NIRS PROBES PLACED ON PATIENTS HAVE RESULTED IN DIFFERENT INJURIES, INCLUDING SKIN TEARS, BURNS, AND PRESSURE INJURIES." THERE WERE NO ADDITIONAL MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 16483278 ↗
• MalfunctionMar 1, 2023Patient Device Interaction Problem

  A US DISTRIBUTOR RETURNED A PATIENT'S ELECTRODE BELT AND REPORTED THAT THE PATIENT WAS EXPERIENCING "CHECK THERAPY PAD" MESSAGES.

  Patient problems: Localized Skin Lesion; Skin Discoloration

  MAUDE report 16459243 ↗
• MalfunctionMar 1, 2023Adverse Event Without Identified Device or Use Problem

  NEAR-INFRARED SPECTROSCOPY (NIRS) PROBE ON LEFT LOWER BACK RESULTED IN A MEDICAL ADHESIVE RELATED SKIN INJURY (MARSI) WITH PARTIAL THICKNESS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16459204 ↗
• MalfunctionMar 1, 2023Adverse Event Without Identified Device or Use Problem

  NEAR-INFRARED SPECTROSCOPY (NIRS) PROBE ON MID BACK (SPINE) RESULTED IN A MEDICAL ADHESIVE RELATED SKIN INJURY (MARSI) WITH PARTIAL THICKNESS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16459202 ↗
• MalfunctionMar 1, 2023Adverse Event Without Identified Device or Use Problem

  NEAR-INFRARED SPECTROSCOPY (NIRS) PROBE ON RIGHT LOWER BACK RESULTED IN TWO SUPERFICIAL SKIN TEARS.

  Patient problems: Skin Tears

  MAUDE report 16459176 ↗
• MalfunctionMar 1, 2023Adverse Event Without Identified Device or Use Problem

  NEAR-INFRARED SPECTROSCOPY (NIRS) PROBE ON LOWER BACK RESULTED IN A MEDICAL ADHESIVE RELATED SKIN INJURY (MARSI) WITH PARTIAL THICKNESS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16459175 ↗
• MalfunctionMar 1, 2023Patient Device Interaction Problem

  NEAR-INFRARED SPECTROSCOPY (NIRS) PROBE ON THE RIGHT FLANK RESULTED IN A STAGE 1 PRESSURE ULCER/INJURY.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 16459141 ↗
• MalfunctionFeb 7, 2023Adverse Event Without Identified Device or Use Problem

  NEAR-INFRARED SPECTROSCOPY (NIRS) PROBE PLACED ON RIGHT FLANK RESULTED IN STAGE 2 PRESSURE INJURY.

  Patient problems: Skin Tears; Superficial (First Degree) Burn

  MAUDE report 16311002 ↗
• MalfunctionJun 8, 2021High Readings; High Readings

  THE CUSTOMER REPORTED THE SENSOR LIFTED OFF THE PATIENT DURING USE CAUSING THE MEASURED VALUES TO INCREASE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11959965 ↗