Arjo was informed about 4 patients falls from arjo atmosair 9000 mattress (medwatch reports numbers 3007420694-2019-00175, 3007420694-2019-00176, 3007420694-2019-00177, 3007420694-2019-00178).Incidents occurred at a healthcare facility located in netherlands taking care of elderly people with dementia.A patient fell from the mattress at night, therefore the fall was not witnessed.There was no injury in relation to this event.Following the customer fall risk protocol, the bed frame used (stiegelmeyer model bett elvido-vano, type 188222) was placed at the lowest position with side rails lowered.Additionally the an alarm device was placed near the bed, to alert caregivers in case patient exit the bed.In the investigated event, the customer staff reacted on the alarm when patient exited the bed.An arjo atmosair 9000 mattress was inspected by arjo representative who did not find a fault.Caregivers have been aware of fall risk and implemented a fall risk intervention as per their protocol.From the above it can be stated that the patient's fall from the bed was most likely related to his medical state and not to atmosair 9000 mattress.Atmosair 9000 user manual states : "side rails and restraints - warning: use or non-use of restraints, including side rails, can be critical to patient safety.Serious or fatal injury can result from the use (potential entrapment) or nonuse (potential patient falls) of side rails or other restraints." "side rails / patient restraints - whether and how to use side rails or restraints is a decision that should be based on each patient's needs and should be made by the patient and the patient's family, physician and caregivers, with facility protocols in mind.Caregivers should assess risks and benefits of side rail / restraint use (including entrapment and patient falls from bed) in conjunction with individual patient needs, and should discuss use or non-use with patient and / or family.Consider not only the clinical and other needs of the patient but also the risks of fatal or serious injury from falling out of bed and from patient entrapment in or around the side rails, restraints or other accessories." to sum up, arjo mattress was used for patient treatment during the reported fall and therefore played role in the event, but did not failed to meet its specification (there was no product failure).The patient fall was most likely related to his medical state.We report this event due to patient fall from arjo mattress.
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The facility's intervention protocol for high risk fall patients is to place side rails in the lowest position and an alarm device is placed near the bed, which alerts caregivers about patient exiting the bed.In the complaint the caregivers reacted on an alarm.When conclusions from the investigation are available, a final report will be provided.
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