MalfunctionFLL

VDTS-100R

Received Aug 5, 2025 · Event occurred Jun 8, 2025

Report 22714205 · MDR key 22714205

Device

Generic name

Continuous Measurement Thermometer

Manufacturer

Ekla Corporation

Lot number

20241113

Product problems

Defective Device

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

NOVA PLUS STANDARD DIGITAL THERMOMETERS DEFECTIVE. THREE THERMOMETERS GAVE THE WRONG RECTAL TEMPERATURE. MODEL # CAT. NO. VDTS-100R, FROM LOT# (B)(4) 20241113. PRODUCT WAS DISCARDED