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Arjo was notified about an incident with involvement of carevo shower trolley.It was reported that during use one side support handle broke and side support had opened.No injury was reported.It was also not indicated that a patient fall occurred.After the incident the device was taken out of use and taken from the customer facility by the 3rd party service provider harting bank.The device was evaluated by the arjo's representative.According to the inspection results, the right side support handle locking latch has been broken off from the right side support foot end.At the left handle it was noticed that the latch is slightly bent and the a spring clip from the end of the handle was missing.Carevo is equipped with two side supports/panels to secure the patient.The side support has three positions, presented in the instructions for use (ifu 04.Ba.08_9 dated on september 2014): inner, outer and down folded.The outer position can be adjusted for more space for the patient.Moreover, there are two comfort handles located on the carevo, one on each side support.The patient can use the comfort handle as support when laying on the side.Holding on to the comfort handle can add a sense of security for the patient as well as a feeling of being able to help out.The side support handle has two latches.One latch on each handle locks the side support on the stretcher frame hooks.The two side support handles claimed due to the investigated incident were returned to the manufacturer for further evaluation.The visual inspection was conducted and revealed that surface of breakage was filed off (with some tool).According to the collected information, the part was filed off by the 3rd party service provider, who wanted to place the part on the second side support, but the exact reason of this action was unknown.The damaged parts were sent to x-ray examination to the external laboratory.Based on results, the checked castings had internal discontinuities of the gas porosity nature, which was assessed to meet the level a2 according to astm e505 (required was at minimum class a3 or similar taking into account the discontinuities nature).The handles which's durability was tested and were able to withstood the force of 1000n (so according to specification) met the requirements of class a3 according to astm e505.On 2018-aug-01 the part that was damaged in the incident was sent for the material composition test to be performed by the external laboratory.Based on the report received on 2018-aug-22 the material composition was according to specification as the examined material was according to the requirements of pn-en 1774:2001 for the grade zinc alloy zl0410, zl5, so met the manufacturer's specification.Arjo made the attempt to recreate the malfunction which occurred during the investigated incident with usage of parts delivered by the same supplier who manufactured handles in question.Arjo performed a test of carevo safety side support handle strength in compliance with the en 60601-2-52, subclause 201.9.8.3.3 (side rail strength and latch reliability).The two performed test attempts were started with 750n of downward vertical force with only one support handle latched/locked.During the first try safety side support handle withstood 140kgs (approximately 1400n) and after that hook in locking frame was damaged (side support handle did not break).During second attempt safety side support handle withstood 145kgs (approximately 1450n) without any visible damages to the tested sample.The general conclusion from the test was that the received results were appropriate to intended use of product.The force applied to the safety side support during test was high enough and was recognized to be hard to achieve during normal use.Therefore the product met stated requirements.Please note that it was not possible to recreate the event and break the side support handle.Arjo carried out the another verification test of the carevo side support design to confirm compliance with the defined requirements.The handles which were used for test were supplied by previous supplier.Firstly, test sample was mounted onto the carevo trolley, properly latched and then force have been applied (500n).Secondly, carevo trolley side supports were unlatched on one side and properly latched on the other side to simulate force distribution in f direction during misuse (500n).Finally, safety side with one unlatched lock was overloaded.Force applied have been doubled (1000n).After the standard tests were finished, specification requirement related with mechanical strength of latch (7500n) has been verified.Received results showed that regardless of the test variant, each side support handle withstood a force about 500n which resulted in no further damages.Additional tests showed that durability of tested side support handle samples highly exceeds specification requirement of 7500n.Tests have been stopped after reaching force of 9500n because testing machine is calibrated to 10000n, further increasing of force would lead to the testing machine damage.Based on the test summary all requirements were met, therefore the test was passed.Received results were appropriate to intended use of product.Safety side handles were not deforming or breaking during normal use.Please note that it was not possible to recreate the event and break the side support handle.The carevo shower trolley instructions for use (ifu 04.Ba.08_8 dated on june 2013) provides information regarding usage of the device and states that: "the carevo equipment must be used by appropriately trained caregivers with adequate knowledge of the care environment, its common practices and procedures, and in accordance with the guidelines in the instructions for use".The caregiver should position the patient in the carevo with the patient's head towards the head end and feet towards the foot end.Caregiver should also make sure the patient's hips are centrally positioned over the flexi zone.The ergo-access area is intended for caregiver to be able to reach the patient better.The caregiver using the device is obligated to check if all parts are in place before every use as well as a thorough inspection for damage.If any part is missing or damaged the product should be removed from service until is repaired (ifu).Moreover, the ifu warns user about the necessity of checking if side supports are properly closed and locked: "to avoid patient from falling out of the device make sure that all side supports are in a locked position", additionally it is stated in the user manual, that the caregiver should lift the opening handles and raise/lower the side support to the selected position until it locks and clicks into place.If the opening handles will not lock the caregiver should remove the patient and make a visual check.If check result reveals any malfunction, the caregiver should contact qualified personnel.The check of opening handles to confirm that they lock properly is a part of every week functionality test routine.The carevo involved in the incident was manufactured over two years before to incident occurred.The side support handles were not replaced during this period.As per confirmation provided by the arjo representative, the device's maintenance was carried out by the 3rd party service provider (harting bank).The service records for this unit were not made available for arjo representative.According to the procedure described in maintenance and repair manual (09.Ba.03_3gb issued in december 2014) the below should be followed: "(f) side support with handles and cover, note if bracket on each handle is missing.If bracket is missing, handle must be replaced." "perform full feature functionality test.Demands for approval: free movement, secure locking inner and outer position".In course of the investigation it was not possible to determine the exact cause of the incident, also due to lack of information regarding circumstances of event.It should be taken into account that if the device was used without proper care and if the accidental impact occurred e.G.During transport of the device or patient care and transfer and care, it may have caused a deterioration of the material endurance due to excessive forces.It should be underlined that the second part was not damaged in the same way, but the part did not have a spring clip from the end of the handle, which was bent in place of this missing component.The spring would normally increase parts durability.The performed tests and analyzes confirmed that design of the carevo side support should assure handles endurance to damage, even when misuse occurs and only one handle is locked in position.Unfortunately, it was not possible to determine if the caregiver inspected device before use.The review of reportable events with the involvement of carevo shower trolleys in last years, revealed a low number of other incidents where it was indicated that side support opened unintended during use due to handle damage.In conclusion, the product failure occurred and the device did not meet manufacturer specification.The lift was used for patient hygiene at the time of event and therefore was directly involved with the reported incident.This complaint was decided to be reported to the competent authorities in abundance of caution and due to limited information about the event which in combination with use error might result in patient fall.
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