Device evaluation of electrode belt sn (b)(4) has been completed.The reported problem (arrhythmia alarms) was confirmed.As received, the belt failed the therapy electrode (te) recognition test.Upon evaluation, there was an open pulse wire inside the cable connecting the distribution node (dn) and front te, between ecg electrode a and ecg electrode b.The cause of the constant gong alarms is the open wire.There was no death or adverse event associated with the belt malfunction.
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02/25/2021.Resubmitting this mdr as part of an internal audit where the electronic 3500a pdf form could not be located.The internal audit indicates that the electronic 3500a form, within the esubmitter application, was created on (b)(6) 2018.Acknowledgements 1, 2, and 3 could not be located.A us distributor returned an electrode belt indicating that a patient was experiencing false arrhythmia alarms.
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