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

Device Problems Failure to Transmit Record (1521); Patient Data Problem (3197); Intermittent Communication Failure (4038)

Patient Problem Arrhythmia (1721)

Event Date 09/22/2022

Event Type  malfunction  

Event Description

The patient suffered a cardiac event during mobile cardiac telemetry monitoring.

Manufacturer Narrative

The patient was hospitalized after approximately 1 day of the prescribed 14-day wear period.An episode of slow atrial fibrillation occurred on (b)(6) 2022 at 10:43:31am during the wear period but was only partially transmitted to irhythm servers.The complete episode was captured on the final report.The timeline of events is as follows: the patient was originally admitted to the hospital at an unknown date, with symptoms which included possible dysarthria and pre-syncope, and inability move from a sitting to standing position.The patient was discharged on (b)(6) 2022 and had a zio at device placed in their physicians office on the same day.The patient's symptoms continued and the patient was again hospitalized on (b)(6) 2022 due to a syncopal episode.The patient removed the device on (b)(6) 2022 due to being in hospital.On 19-sep-2022 the device was returned to irhythm and the data was processed for inclusion on the final report.An analysis of the diagnostic data was completed 13-oct-2022 and confirmed that gateway cell connections were interrupted which could have attributed to the missed transmission.The cause of the interrupted communication was attributed to cellular connectivity issues.No health consequences are attributed to the malfunction as the patient was already in the hospital when the malfunction occurred.The zio at ecg ambulatory monitoring system is intended to capture, analyze and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram (ecg) information for long-term monitoring.The zio at is not indicated for in-hospital monitoring of critical care patients.

• 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 CA 90630
• Manufacturer Contact: mazi kiani ; 699 8th st; suite 600; san francisco, CA 94103 ; 9494132147
• MDR Report Key: 15621514
• MDR Text Key: 307087596
• Report Number: 3007208829-2022-00050
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 12/13/2022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2022
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2022
• 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 Outcome(s): Hospitalization; Other
• Patient Age: 82 YR
• Patient Sex: Male