MAUDE Adverse Event Report: IRHYTHM TECHNOLOGIES, INC ZIO AT; DETECTOR AND ALARM, ARRHYTHMIA

Device Problem Failure to Sense (1559)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2022

Event Type  malfunction  

Manufacturer Narrative

Following the wear-period and while compiling the final report, a 4.5 second pause was discovered which met the device¿s automatic detection criteria and not transmitted.Irhythm clinical operations contacted the account to notify them of the missed transmission and to determine patient impact.During the call, irhythm was notified that the patient was admitted to the hospital following the wear-period for symptoms consistent and associated with a previous pre-syncopal episode; the account confirmed no harm/delay in care resulted from the delayed notification.Analysis of the diagnostic data determined the most likely cause of the missed episode transmission is algorithm sensitivity.The zio at ecg monitoring system is intended to capture, analyze and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram (ecg) information for long-term monitoring.While continuously recording patient ecg, both patient-triggered and automatically detected arrhythmia events are transmitted to a monitoring center for reporting.After wear, a final report is generated based on beat-to-beat information from the entire ecg recording.It is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety.The reports are provided for review by the intended user to render a diagnosis based on clinical judgment and experience.It is not intended for use on critical care patients.

Event Description

The patient experienced an arrhythmia that was not detected by the device¿s automatic detection feature and was subsequently not transmitted to irhythm servers during the wear-period. the event was found when compiling the final, full-data report by certified cardiographic technician.

• Brand Name: ZIO AT
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES, INC; 699 8th st suite 600; san francisco CA 94103
• Manufacturer (Section G): IRHYTHM TECHNOLOGIES, INC; 6550 katella avenue, suite 200; cypress AZ 90630
• Manufacturer Contact: mazi kiani ; 699 8th st suite 600; san francisco, CA 94103 ; 9494132147
• MDR Report Key: 15780299
• MDR Text Key: 307582960
• Report Number: 3007208829-2022-00053
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• PMA/PMN Number: K163512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/01/2023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2022
• Initial Date Manufacturer Received: 10/17/2022
• Initial Date FDA Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Male