inforMED
MalfunctionILK

6257 XPEDITION HIGH CONFIG

Received Jul 2, 2024 · Event occurred Jun 13, 2024

Report 0001831750-2024-00729 · MDR key 19660566

Device

Generic name

Transport, Patient, Powered

Catalog number

625705550002

Product problems

  • Difficult to Fold, Unfold or Collapse
  • Device Fell
  • Difficult to Fold, Unfold or Collapse
  • Device Fell

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE FRAME WAS BENT CAUSING IT TO DROP. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

Additional Manufacturer Narrative

THE DEVICE WAS EVALUATED AND FOUND TO NOT BE REPORTABLE. SECTION H CODES HAVE BEEN UPDATED.

Description of Event or Problem

IT WAS REPORTED THAT THE FRAME WAS BENT CAUSING IT TO BE DIFFICULT TO FOLD/UNFOLD. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.