Arjo became aware of an event involving a nimbus 4 mattress.According to the report forwarded by the police to arjo, a paraplegic patient fell out of the mattress and was found on the floor.He was lifted back into the bed using the hoist.The patient's condition had progressively deteriorated and the patient passed away.The nimbus mattresses consist of a top cover which covers the mattress support surface consisting of the sheet with air-filled cells under which is located the automatt sensor pad (mattress base).Based on the photographic evidence provided, the mattress was over-inflated what contributed to the patient fall from the device.The involved mattress was returned to arjo on 12 oct 2022 and inspected the same day.Based on the results of the mattress evaluation, the cause of the mattress base failure was an incorrect circulation of the air in the automatt sensor pad.The failure was caused by a damaged inner tube of the automatt sensor pad.The tube is made of tpu (thermoplastic polyurethane) and is responsible for transporting the air to the automatt sensor pad.When the tube cracks, the air is accumulated in a sealed automatt sensor pad cover, causing its over-inflation.The analyzed issue (automatt over-inflation) was addressed by the field safety corrective action (fsn-suz-001-2021, resh#87752) that has been already completed on the us market.In summary, the mattress was faulty and from that perspective, the nimbus mattress did not meet the performance specification.The reported issue occurred when the device was used by the patient, therefore, the arjo product was directly involved in the reported incident.The complaint was assessed as reportable due to the patient fall from the mattress resulting in death.
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