The claimed beds were inspected and repaired internally by the facility staff.The indigo power supply cables were replaced and after functionality testing, beds were released for use.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.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for cuts, abrasions, kinks or other deterioration.When any malfunction is noticed, the device should be immediately withdrawn from the user until the service is performed.To sum up, the complaint was decided to be reportable due to the power supply cable malfunction resulted in sparks.This component was found to be damaged and from that perspective, the device did not meet performance specifications.There was no indicatin regarding patient involvement when the malfunction was observed.
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