Arjo was informed about 7 patients falls from arjo pentaflex mattress (medwatch reports numbers 3007420694-2019-00173, 3007420694-2019-00179, 3007420694-2019-00180, 3007420694-2019-00182, 3007420694-2019-00189, and 3007420694-2019-00190).Incidents occurred at a healthcare facility located in netherlands taking care of elderly people with dementia.A patient was found on the edge of the bed, almost rolling out of the bed.A caregiver who accidently came into the room could not prevent the fall but supported the patient safely placing him on the floor.There was no injury.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, an alarm device was placed near the bed to alert caregivers in case patients exit the bed.An arjo pentaflex mattress was inspected by arjo representative who did not find a fault.From the above, it can be concluded that the patient's fall from the bed was most likely related to patient medical state and not to pentaflex mattress.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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