Arjo was informed by a customer representative about an event involving an arjo auto logic pump.Following information reported, a damaged power cord allegedly caused a white flash and short circuit in the room in which the pump was used.No injury nor other medical consequences were reported to arjo.During the inspection of the involved device performed by arjo representative, it was found that the main power cable was physically damaged and burnt.The pump was installed on the bed by the customer's staff without use of the cable management system.The damaged of the power cord occurred when the cable laid on the floor and was run underneath the bed.According to instruction for use, (630933en), the user shall ¿make sure that the power cables (¿) are clear of moving bed mechanisms or other possible entrapment areas.The mains power cable of this pump is designed to allow movement of the bed, and should be fitted into the cable management flaps along the sides of the mattress, as described in this manual.¿ the main cable should be carefully inspected.When any malfunction is noticed, the device should be immediately withdrawn from the use until the service is performed.The complaint was decided to be reportable due to malfunction of the power cord which resulted in the white flash.The power cord was found to be damaged and from that perspective, the device did not meet performance specification.The device was in use by the patient when the malfunction occurred.No injury or other medical consequences were reported.
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