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

Device Problem Failure to Transmit Record (1521)

Patient Problems Arrhythmia (1721); Atrial Fibrillation (1729)

Event Date 08/30/2021

Event Type  malfunction  

Manufacturer Narrative

The patient was hospitalized for fainting.The device was placed on the patient on (b)(6) 2021 in their physician¿s office.There were no transmissions received for 5 days at which point irhythm contacted the account to notify them.The preliminary investigation revealed gateway a128120837 was not successfully activated, and no transmissions were received during the wear period.The gateway failed to activate because it encountered a low battery fatal error.There were clinically actionable arrhythmias which did not get transmitted to irhythm¿s idtf (42 cfr 410) and therefore neither was the physician notified.

Event Description

Per an update to the criteria for reportable events, this mdr is being submitted.On 08dec2022 a patient was hospitalized while wearing the zio at ecg monitor.The original event occurred on (b)(6) 2021.It was reported that the patient was hospitalized due to fainting while wearing the zio at ecg monitor.

• 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: 16092146
• MDR Text Key: 308491174
• Report Number: 3007208829-2023-00001
• 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: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 01/23/2022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2021
• 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
• Patient Age: 90 YR
• Patient Sex: Female