inforMED
InjuryILJ

SYSTEM 2000

Received Jun 10, 2020

Report 1419652-2020-00029 · MDR key 10137663

Device

Generic name

Bath, Hydro-massage

Model number

AP01201-GB

Product problems

  • Device Fell
  • Device Fell

Patient

Not reported

  • Bone Fracture(s)
  • Bone Fracture(s)

Narrative

Description of Event or Problem

ARJO HAS BEEN NOTIFIED ABOUT THE INCIDENT WITH INVOLVEMENT OF SYSTEM 2000. THE CUSTOMER STATED THAT THE BATH DROPPED SUDDENLY ON THE CAREGIVER¿S FOOT WHILST SHE WAS WASHING BED COVERS IN BATH. THE BATH WAS HALF FILLED WITH WATER AT THIS TIME. ANOTHER CARER ATTENDED AND LIFTED BATH OFF HER FOOT. THE CUSTOMER FACILITY STATED THAT THE CARER FRACTURED HER BIG TOE. THE INJURED CARER ATTENDED A&E DEPARTMENT. ACCORDING TO THE INFORMATION FROM THE CUSTOMER FACILITY, THEIR IN HOUSE INVESTIGATION DID NOT IDENTIFY ANY ISSUES WITH THE DEVICE. THEY WERE NOT ABLE TO ESTABLISH HOW THIS ACCIDENT COULD HAVE HAPPENED AND WHY THE BATH WOULD HAVE DROPPED.