The evaluation of the device performed by an arjo representative revealed that there was a small burn mark on the indigo power supply cable, no signs of insulation damage were observed.After opening the insulation, it was found that the internal wires were broken.The indigo power supply cable was replaced, the cable routing was corrected and the bed's proper functionality was confirmed during testing.An investigation performed by the manufacturer revealed that the damage of the power supply cable was a result of the inner wire deterioration due to stress applied during up and down movements of the bed.Corrective and preventive action (capa) has been commenced to address the issue and prevent it from reoccurring.Actions taken in the course of the capa ensure that newly manufactured devices will be free of the recognized failure mode and the affected devices will be corrected effectively.On 19 may 2021, the field safety corrective action (fsca, internal number (b)(4) submitted to fda under no.3007420694-05/24/21-001-c) has been commenced to all arjo customers owning the bed equipped with indigo module.The customer that reported the issue received fsn on 08 jun 2021.The instructions for use for the enterprise 9000x (746-591) include the following warnings: ¿disconnect the bed from the electricity supply before starting any cleaning and maintenance activity.¿ ¿do not allow the mains plug or power supply cord to get wet.¿ as per the preventive maintenance section of the instructions for use for indigo (416260), the indigo cables should be examined for cuts, abrasions, kinks or other deterioration.When any malfunction is noticed, the device should be immediately withdrawn from use until the service is performed.To sum up, the complaint was decided to be reportable due to the indigo power supply cable malfunction resulted in sparks and black marks.This component was found to be defective and from that perspective, the device did not meet performance specifications.There was no patient involved when the malfunction was observed.
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