The investigation performed by the manufacturer revealed that the damage was caused by 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 instructions for use for the enterprise 8000x (746-585) 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for cuts, abrasions, kinks or other deterioration.When any malfunction is noticed, the device should be immediately withdrawn from use until the service is performed.To sum up, the complaint was decided to be reportable due to the indigo power supply cable malfunction resulted in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.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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