Device evaluation of electrode belt sn (b)(4) has been completed.The reported problem (non-functional therapy electrodes) has been confirmed.As received, the electrode belt failed a therapy electrode recognition test and the dn (distribution node) to rear therapy electrode cable was pulled from strain relief.Upon investigation, there was a broken solder joint connecting the rear pulse wires inside the distribution node (dn).The cause of the broken joint was the pulled cable.The cause of the test failure and the non-functional therapy electrodes was the broken solder connection.The root cause of the pulled cables was excessive force.No adverse events occurred as a result of the defective electrode belt.
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10/19/2020: resubmitting this mdr as part of an internal audit where the electronic 3500a pdf form was located, and acknowledgements 1, 2, and 3 could not be located.A us distributor returned electrode belt sn (b)(4) and reported that the belt had a damaged cable.
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