inforMED
MalfunctionITH

DECOMPRESSION OF CHOICE

Received May 17, 2024 · Event occurred Apr 29, 2024

Report 3007278668-2024-00002 · MDR key 19342108

Device

Generic name

Decompression Table

Model number

E9011

Product problems

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

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

THE CUSTOMER CONTACTED THE MANUFACTURER TO REPORT THAT AS THEY WERE UNCRATING THE TABLE AND WERE IN THE PRCOESS OF MOVING THE TABLE, THE LUMBAR SECTION OF THE TABLE WAS OBSERVED AS NOT BEING HORIZONTAL AND LEVEL WITH THE OTHER CUSHION SECTIONS, IT WAS TIPPED DOWNARD. PICTURES WERE SENT BY THE CUSTOMER TO THE MANUFACTURER AND IT WAS DETERMINED THAT THERE MAY BE A PARTIAL WELD BREAK AND THE IMMEDIATE DECISION WAS MADE TO HAVE THE TABLE SHIPPED BACK TO THE MANUFACTURER. THERE WAS NO PATIENT CONTACT WITH THE DEVICE.

Remedial action

  • Replace