This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.The device was built before tamper seal was implemented.There was no physical damage on the device.The technician powered on off the unit and changed parts.The reported issue was confirmed after power on the returned 6004001 monitor with error code e-04 and error 20.The technician measured the coin battery with.25voltage (v) (spec:3v).What caused the reported (primary) problem: the root cause of the reported issue was found to be drained coin battery due to wear.The technician replaced coin battery.Additional heic this mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.The device was built before tamper seal was implemented.There was no physical damage on the device.The technician powered on off the unit and changed parts.The reported issue was confirmed after power on the returned 6004001 monitor with error code e-04 and error 20.The technician measured the coin battery with.25voltage (v) (spec:3v).What caused the reported (primary) problem: the root cause of the reported issue was found to be drained coin battery due to wear.The technician replaced coin battery.
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