Device evaluation of belt sn (b)(4) has been completed.The reported problem (check te, adjust belt messages) was confirmed.As received, the belt failed incoming therapy electrode (te) recognition testing.Upon evaluation, there was an open pulse wire inside the cable connecting the distribution node (dn) and front te, between the dn and ecg electrode b.The cause of the non-functional therapy electrodes is the open wire.The root cause of the open wire is excessive force placed on the cable.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 an electrode belt indicating that a patient was receiving "adjust belt" and "check therapy pad" messages.
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