inforMED
MalfunctionITH

DECOMPRESSION OF CHOICE

Received May 16, 2024 · Event occurred Apr 26, 2024

Report 3007278668-2024-00001 · MDR key 19336621

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

Additional Manufacturer Narrative

THE CUSTOMER WAS UNCRATING THE PRODUCT AND MOVING THE DEVICE WHEN THE LUMBAR END OF THE TABLE WAS IDENTIFIED AS BEING LOOSE. WHEN THE DEVICE CONTINUED TO BE MOVED THE DOCTOR DETERMINED THAT THE LUMBAR ADJUSTMENT SECTION OF THE DEVICE WAS HANGING LOW INSTEAD OF HORIZONTAL AND AT THAT TIME THE CUSTOMER COULD SEE BETWEEN THE LUMBAR AND THORACIC CUSHIONS THAT A WELD HAD BEEN COMPROMISED ON THE FRAME. THE CUSTOMER CONTACTED PIVOTAL HEALTH SOLUTIONS AND SENT A PICTURE AND PIVOTAL HEALTH SOLUTIONS WAS ABLE TO VERIFY THAT A WELD HAD FAILED AND THEN TOOK IMMEDIATE ACTION TO HAVE THE TABLE RETURNED TO THE MANUFACTURER. THERE WAS NO PATIENT USE ON THIS DEVICE.

Description of Event or Problem

THE WELD ON THE LUMBAR SECTION OF THE TABLE FAILED.

Remedial action

  • Replace