OCEAN VIP ERGO

Additional Manufacturer Narrative

THIS EVENT TOOK PLACE IN SWEDEN WITH A 1-YEAR OLD AQUATEC OCEAN VIP ERGO SHOWER COMMODE. IT IS BEING REPORTED DUE TO THE AQUATEC OCEAN VIP ERGO SHOWER COMMODE IS ALSO SOLD IN THE UNITED STATES. THE AFFECTED AQUATEC OCEAN VIP ERGO COMMODE NOR THE FOOTRESTS, HEEL STRAPS OR CALF STRAPS WERE RETURNED FOR INVESTIGATION. PICTURES OF THE DEVICE WERE RECEIVED. THE PICTURES SHOWED THAT THE HEEL STRAPS AND CALF STRAPS WERE PRESENT ON THE DEVICE. ALTHOUGH BOTH STRAPS WERE INSTALLED ON THE COMMODE, THE PATIENT STILL MANAGED TO MOVE HIS FOOT OVER THE HEEL STRAP, PAST THE CALF STRAP TO THE BACK AND FINALLY UNDER THE METAL TUBE OF THE FOOTREST. FROM THE PICTURES IT CANNOT BE DETERMINED IF THE STRAPS WERE INSTALLED CORRECTLY OR IF THEY WERE IN THE PROPER POSITION FOR THE END USER. THE HEEL STRAPS AND THE CALF STRAP ARE INTENDED TO ENSURE THAT THE PATIENT'S FEET ARE SECURELY POSITIONED ON THE PLATES OF THE FOOTRESTS DURING THE USE OF THE DEVICE. IT IS VERY UNLIKELY THAT A PATIENT GETS IN CONTACT WITH THE LOWER ENDS OF THE METAL TUBES OF THE FOOTRESTS DURING NORMAL AND INTENDED USE OF THE DEVICE, ESPECIALLY IF THE HEEL STRAPS ARE INSTALLED AND ADJUSTED CORRECTLY FOR THE PATIENT. FACTORS CONTRIBUTING TO THE INCIDENT COULD INCLUDE: THE END USER¿S PRE-EXISTING CONDITION WITH SPASTICITY, THE HEEL STRAPS, CALF STRAPS OR OTHER PARTS OF THE DEVICE, WERE NOT CORRECTLY ADJUSTED OR FITTED FOR THE SPECIFIC NEEDS OF THIS PATIENT.

Description of Event or Problem

THE PATIENT WITH SPASTICITY MANAGED TO LIFT HIS FOOT (OVER THE HEEL BAN) AND BACK, CAUSING HIS HEEL TO HIT THE BOTTOM OF THE METAL TUBE OF THE FOOTREST RESULTING IN A WOUND REQUIRING SUTURES.