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Device Problem
Failure to Transmit Record (1521)
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Patient Problem
Unspecified Heart Problem (4454)
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Event Date 09/22/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Per irhythm process in place at the time of this event, when a transmission limit had been reached, the zio at daily report would reflect that to the hcp account through ¿trigger off¿ icons.Irhythm became aware of the arrhythmia while preparing final report and notified the hcp on day 107.In keeping with fda¿s position on reporting expectations as communicated to the company in may 2023, irhythm aligned to a reporting approach for mdns that were not communicated during the wear period due to a maximum transmission limit being reach, and agreed to treat these instances as malfunction mdrs for reporting purposes.This report does not constitute an admission by irhythm that the product described in this report has any defects or has malfunctioned.Certain terms included in form fda 3500a and related mdr.
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Event Description
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No adverse events, such as death or serious injury, are known to have occurred.The patient experienced an arrhythmia that met the criteria for medical doctor notification (mdn) (arrhythmias of clinical interest during the product wear period) for the hcp location, but that was not conveyed to the hcp location during the wear period.The investigation confirmed that the zio at reached the asymptomatic maximum transmission limit for the zio at device.Also, under the process in place at the time of this event, when a transmission limit had been reached, the zio at daily report would reflect that to the hcp account through ¿trigger off¿ icons.
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Search Alerts/Recalls
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