inforMED
MalfunctionGWN

INTERACOUSTICS

Received Dec 8, 2023 · Event occurred Nov 10, 2023

Report 9710051-2023-00001 · MDR key 18292852

Device

Generic name

Orion

Manufacturer

Interacoustics A/s

Model number

COMPREHENSIVE

Catalog number

8537269

Product problems

  • Detachment of Device or Device Component
  • Detachment of Device or Device Component

Patient

Unknown

  • Head Injury
  • Head Injury

Narrative

Description of Event or Problem

DURING A VESTIBULAR EXAMINATION A ROTATING OVERHEAD PROJECTOR WHICH IS PART OF THE EXAMINATION EQUIPMENT BECAME DETACHED FROM IT'S SUPPORT AND FELL, CREATING A "GASH" TO THE PATIENTS HEAD. THE PATIENT WAS SENT TO THE ER. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN.