inforMED
MalfunctionCCW

PROVU

Received Oct 1, 2025 · Event occurred Aug 27, 2025

Report 3006061749-2025-00057 · MDR key 23188659

Device

Generic name

Video Laryngoscope

Catalog number

040-07-0035U

Lot number

SUYD67086.

Product problems

  • Activation, Positioning or Separation Problem
  • Activation Problem
  • Key or Button Unresponsive/not Working
  • Activation, Positioning or Separation Problem
  • Activation Problem
  • Key or Button Unresponsive/not Working

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

DURING FULL ARREST, WE HAD DIFFICULTY TURNING THE CAMERA OFF AND ON. AFTER INSPECTING THE STATION, WE NOTICED THAT THE BUTTON ONLY RESPONDS WHEN PRESSED FIRMLY IN RIGHT CORNER. THIS MADE IT CHALLENGING TO OPERATE. NO REPORT OF SERIOUS INJURY / HARM TO PATIENT OR USER. NO REPORT OF DIRECT HARM. NO REPORT OF INDIRECT HARM. NOT REPORTED AS HAVING REQUIRED INTERVENTION TO PREVENT DAMAGE. NOT REPORTED AS REQUIRING HOSPITALISATION - INITIAL OR STAY PROLONGED BY ONE DAY OR MORE. NO REPORT OF SERIOUS INJURY, DISABILITY OR PERMANEENT IMPAIRMENT. NOT REPORTED AS LIFE THREATENING. NO DEATH REPORTED.