The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by microport crm that was cleared or approved by fda for marketing in the united states.Investigation results: at device reception, the subject home monitor was tested and the reported issue was confirmed.The device does not work anymore.Based on the provided event description and the observations made during the expertise, it can be suspected that the power supply connector of the home monitor is damaged.The root cause of this issue could not be determined; however, it could have resulted from the wear of the power supply connector over time or from a mechanical shock.
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