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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 09/06/2023 |
Event Type
malfunction
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Event Description
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The patient experienced an arrhythmia that met medical doctor notification (mdn)requirements that was not transmitted during the wear period.The investigation confirmed the zio at reached the asymptomatic maximum transmission limit described in the product labeling.The hcp account was notified that the device was approaching the asymptomatic transmission limit prior to reaching the limit, according to standard process, and a replacement device was shipped.Follow-up with the account confirmed they were already aware of the arrhythmia and handling the issue.No adverse events, such as death or serious injury, are known to have occurred.
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Manufacturer Narrative
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The patient experienced an arrhythmia that met medical doctor notification (mdn) requirements that was not transmitted during the wear period.The investigation confirmed the zio at reached the asymptomatic maximum transmission limit.No adverse events, such as death or serious injury, are known to have occurred.The device was worn for approximately 7 days of the 14-day prescribed wear-period.The device last transmitted and reached the maximum transmission limit 3 days after it was activated.The hcp account was notified on day 3 that the device was approaching the asymptomatic transmission limit, and a replacement device was shipped.There was no patient notification performed at that time as the account requested that the patient not be contacted unless they needed to go to the emergency room.Irhythm became aware of the arrhythmia while preparing final report and notified the hcp on day 19.As described in product labeling, the zio at device has a maximum threshold of transmitting 100 patient triggers and 500 asymptomatic transmissions during wear.When a patient is approaching the limit for either transmission type, irhythm reaches out to the account to determine whether to send another at device to the patient.Patient-triggered symptomatic transmissions are still able to be transmitted beyond this limit by pressing the large central button located on the outer device housing.This event is being reported per 21cfr 803 as a product problem /malfunction.This report does not constitute an admission by irhythm that the product described in this report has any defects or has malfunctioned.These terms are included in form fda 3500a and are fixed terms for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.
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Search Alerts/Recalls
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