|
Arjohuntleigh was notified by the customer about an incident with calypso hygiene lifter.The customer reported that a resident was being given a bath with one person assisting.After the bathing, when the staff lowered the bath tub and raised the calypso chair to remove the resident from the bath tub, a bath chair was swinging out over the floor and resident began to slip.A resident was trying to prevent the resident fall, but swung the chair back over the bath tub and the resident slipped out off of the chair.In a result the resident received bruise on forehead.The treatment included ice administration.
|
|
Investigation has been carried out to this complaint and the conclusions are following.Arjohuntleigh was notified by the customer about an incident with calypso hygiene lifter.The customer reported that a resident was being given a bath with one person assisting.After the bathing, when the staff lowered the bath tub and raised the calypso chair to remove the resident from the bath tub, a bath chair was swinging out over the floor and resident began to slip.A caregiver was trying to prevent the resident fall, but swung the chair back over the bath tub and the resident slipped out of the chair completely.In a result the resident received bruise on forehead.The treatment included ice application.An arjohuntleigh representative inspected the lift after the event and found all functions of the lift, brakes in full working order, seat belt was in good condition, also.Calypso hygiene chair is intended for lifting and transporting residents to and from a bathroom in a care facility and to assist with the bathing process.The occurrence rate for the reported incident where a patient fall from the chair because is not positioned correctly and safety belt is not applied is low.A root cause of the reported incident was analyzed.As reported by the customer, at the time of the incident the safety belt was not used because the caregiver, who took care of the resident that moment, was not aware of belt existence and was not aware how to use it.Additional information indicated that the chair was swinging, which would suggest that the center of gravity was disturbed, most likely because patient was incorrectly positioned.Device history record was reviewed and it could be confirmed that the safety belt was attached to the order, initially.As indicated by an arjohuntleigh service technician, it might happen that during cleaning of the device at the customer site, the belt was removed and not attached back to the lift.After the incident the customer staff checked all the lifts in the facility to make sure the safety belts are in place and to ensure that the belt from the reported lift returned to the lift.The result of the check was that all calypso hygiene chairs were equipped with the safety belt.The calypso instruction for use (ifu) states to read the instruction before using calypso lift and hygiene chair.In case further information are required it is encouraged to contact arjohuntleigh representative who can offer support.Ifu indicates that the calypso must be used by appropriately trained caregivers with adequate knowledge of the care environment, its common practice and procedure, and in accordance with the guidelines in the instruction for use.Ifu warns "to avoid falling, make sure that the patient is positioned correctly and that the safety belt is being used, properly fastened and tightened".The safety belt shall be used whenever a resident is being moved.The steps how to use the safety belt are described and presented in graphic for better understanding.Handling instruction after bathing states to "let the bath water out and fold the hand rest forward/downward and sit the patient up.Fold the backrest forward/downward and fasten the safety belt over the chest.Lower the bathtub, so that the calypso lift and hygiene chair is above the water and give the patient a shower." it is worth noting, that the customer received a training from arjohuntleigh representative last year (not exact date was provided).An arjohuntleigh service technician could confirm that the customer staff, that took care of the resident during an incident, did attend three days of training.It is unknown, however, why the caregiver did not adhere to the device instruction for use.From the above it seems that the resident fall from the calypso chair was most likely a result of multiple use errors: not following ifu in regards to using safety belt, failure to provide safety patient transfer from the bath tub, disturbance in gravity would mean that the patient was positioned incorrectly on the chair.After the incident a customer was advised to provide additional training to their staff regarding safety belt usage.A customer requested a follow-up training from arjohuntleigh representative.This will be scheduled upon customer's convenience.In conclusion, there was not product failure, the device met manufacturer specification.The lift was used for patient hygiene at the time of event and therefore was directly involved with the reported incident.We report this incident because of patient fall, which may result in high severity if to recur.
|
