Device evaluation of electrode belt sn (b)(4) has been completed.The reported problem (service code, adjust belt messages, false arrhythmia/asystole alarms ) has been confirmed.Upon investigation the electrode belt was unable to communicate with a monitor.The cause for the failure was isolated to an open orange (+5v) wire in the trunk cable.In addition, there was an open pulse wire in the cabe connecting the front te and ecg a.The root cause for the open wire was excessive force.There was no death or adverse event associated with the belt malfunction.
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03/22/2021- 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 12/20/2018.Acknowledgements 1, 2, and 3 could not be located.A us distributor reported that a patient's lifevest was displaying a service code, false arrhythmia/asystole alarms, and "adjust belt" messages.
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