inforMED
MalfunctionILY

104 LED CLUSTER PROBE WAVELENGTH = 660NM & 850NM ISSUE 1

Received Dec 7, 2023 · Event occurred Sep 22, 2022

Report 3003899624-2023-00006 · MDR key 18280667

Device

Generic name

104 Led Cluster Probe Wavelength = 660nm & 850nm Issue 1

Model number

S2140

Product problems

  • Excessive Heating
  • Excessive Heating

Patient

Unknown

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

Narrative

Additional Manufacturer Narrative

FAULT CONFIRMED - DIODES REPLACED. THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS MADE TO THE COMPANY'S COMPLAINT HANDLING PROCESSES. THIS EVENT IS BEING FILED IN ACCORDANCE WITH A CAPA WHICH HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING.

Description of Event or Problem

PROBE BECOMES VERY HOT.

Remedial action

  • Repair