inforMED
MalfunctionNRB

ULTRAMIST SINGLE USE APPLICATOR

Received May 3, 2023 · Event occurred Apr 24, 2023

Report 16859928 · MDR key 16859928

Device

Generic name

Wound Cleaner, Ultrasound

Manufacturer

Dynamic Group

Model number

AS-55057

Catalog number

AS-55057

Lot number

A2623-1

Product problems

  • Display or Visual Feedback Problem

Patient

Unknown

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

ULTRAMIST APPLICATORS, WHEN APPLIED TO ULTRAMIST DEVICE, ARE NOT DETECTED AND RESULT IN ERROR MESSAGES. THE ERROR MESSAGES DOES NOT ALLOW APPLICATOR TO BE USED AND IT IS WASTED. WE CURRENTLY HAVE (2) APPLICATORS WITH THIS CONCERN. ONE APPLICATOR SHOWS ERROR 200 -- REPLACE APPLICATOR (THIS IS A BRAND NEW APPLICATOR). THE OTHER APPLICATOR SHOWS ERROR 203 -- NOT READING APPLICATOR.