inforMED
MalfunctionMUD

INVOS

Received Jun 22, 2026 · Event occurred May 3, 2026

Report 25577017 · MDR key 25577017

Device

Generic name

Oximeter, Tissue Saturation

Manufacturer

Covidien Lp

Model number

PEDATRIC SENSOR

Catalog number

PMSENS71-P-20

Patient

7 MO · Female

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

FOLLOWING IMPLEMENTATION OF THE UPDATED NIRS SYSTEM, STAFF HAVE REPORTED PERSISTENT SENSOR ADHESION FAILURES WITH THE NEW ACRYLIC-BASED PEDIATRIC AND ADULT SENSORS, INCLUDING FREQUENT DETACHMENT FROM THE PATIENT¿S SKIN AND INCONSISTENT SIGNAL ACQUISITION DESPITE ADHERENCE TO UPDATED APPLICATION GUIDANCE (SKIN PREP, PRE-WARMING, AND SECURING TECHNIQUES). THESE ISSUES HAVE BEEN OBSERVED ACROSS MULTIPLE UNITS EVEN AFTER VENDOR-SUPPORTED EDUCATION.