MalfunctionMUD
INVOS
Received Jun 22, 2026 · Event occurred May 3, 2026
Report 25577017 · MDR key 25577017
Device
Generic name
Oximeter, Tissue Saturation
Manufacturer
Covidien LpModel number
PEDATRIC SENSORCatalog 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.