|
Initially it was reported by arjohuntleigh representative that fell to the floor with a bath's chair: "resident in whirlpool chair, as she was lower to the floor the caregiver released the latch causing the chair to tip to the left at floor level.Safety belt intact.All latches hooked." injury to the resident: two hematomas on left side of forehead and a small laceration to left arm at elbow.Areas cleansed and clean dry dressing applied to both areas.No hospitalization was required.Device examination showed that bath and seat were in poor condition: "leaking oil from the base.Lots of air in the lines.With no patient on it, the unit bounces.The safety strap was worn and will be replaced".No details about the last maintenance were provided, however the device is not under arjo's service contract.Last training to the on of caregivers was performed in (b)(6) 2007, date of the last training to the second caregiver was not provided.The received information showed that the involved device was purchased by the customer around 1998, therefore it was in use for about 17 years.
|
|
An investigation was carried out into this complaint.When reviewing similar reportable events for century baths we have found a low number of other similar cases where seat detached from lifting unit and tipped.We have been able to establish that there is no complaint trend concerning these kind of events.Please note that arjohuntleigh manufactured about 3000 century baths to date.The device was being used for patient handling and in that way contributed to the event.The received information showed that no malfunction was found that could causes or contributes to the reported incident, it was only noticed that "the chassis had one slightly bent post".However it wasn't possible to re-create this event.Instruction for use (ifu) is provided with each device.Operating and daily maintenance instructions (4.Ak.01/2us9711 intended for old century baths equipped with lifting unit) includes warnings and safety procedures that are necessary for correct and safe use of the product.Instruction warns inter alia: "- equipment must be handled by trained staff only (.) when moving residents: (.) make sure the resident is sitting/lying properly with hands and feet placed on the appropriate rest or with hands crossed over the chest.Make sure all straps are in good condition.Make sure the resident is held securely in the transport device with straps properly routed and fastened, so that no part of his/her body can be injured.Move lifts carefully, especially in narrow passages, over threshold or bumps etc.Make sure chair seats are latched securely and that screws are tight before using the equipment".Instruction provides also information about 'daily safety check': "resident transfer system check the condition of all seat belts, latches and lifting mechanisms on the devices that will be used to transfer residents into the century sit bath system.Century sap-lift transfer latch - test the transfer latch to make certain all parts operate freely and properly.Century saf-kary seat latches - check the seat latches on the century saf-kary frame to ensure that they are operating properly and no parts are missing." instruction informs also about correct use of the product including transfer the patient out of the tub: "transfer with the saf-lift/saf-kary system: raise the saf-lift to its maximum height by stepping on the up pedal until.Use the towel to dry and clean the underside of the chair.This will prevent water from dripping on the floor and keep residue from building up under the seat.Touch the dn pedal briefly to release pressure so the lift will rotate.Before you pivot the resident out of the tub, make sure the lower extremities are towelled dry to avoid getting the bathroom floor wet.Warning! make sure the seat bottom will clear the tub rim by at least two inches before pivoting the resident out of the tub.Failure to do so could result in a disconnect and injury to the operator or resident.To avoid injury to resident or operator due to accidental unlatching, never touch the transfer latch while pivoting the resident into or out of the tub.(.) the saf-kary must be aligned so the transfer plate properly engages with the pins on the saf-kary.Failure to do so could result in injury to the operator or resident.Position the chair over the saf-kary and step on the dn pedal.Lower the seat onto the frame of the saf-kary, guiding the seat so the lower arm transfer plate aligns with the pins of the saf-kary frame.Connect and secure the seat to the saf-kary frame with the yellow-handled latches.Pull the large knob marked "push" to unlock the green lock cover.Lift the green lock cover and hold it up while using a second finger to hold the lock in the open position.At the same time, press the up pedal on the saf-lift and raise the lift until the transfer latch fixed hooks clear the seat arm bar.(.)" our evaluation as presented above constitutes the possibility of user error as not following recommendations included in product instruction for use, cannot be ruled out: - seat incorrectly attached.- the resident was incorrectly positioned on a seat.Please note that the involved bath was in use for about 17 years and device's condition has been described as poor, worn out equipment.This device is not under arjo's service contract, but ifu warns: "if any part of the system is not functioning properly, cease all bathing activities until the problem is corrected by qualified maintenance personnel".
|
