MAUDE Adverse Event Report: IRHYTHM TECHNOLOGIES, INC ZEUS SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number S100

Device Problems Failure to Transmit Record (1521); Communication or Transmission Problem (2896)

Patient Problem Atrial Fibrillation (1729)

Event Date 06/25/2023

Event Type  malfunction  

Event Description

It was reported that the patient experienced an arrhythmia that met medical doctor notification (mdn) requirements that was not transmitted during the wear period.Investigation concluded that the arrhythmia was not transmitted during the wear period because the device did not detect the arrhythmia.No adverse events such as death or serious injury are known to have occurred, however the patient later experienced a syncopal episode.

Manufacturer Narrative

It was reported that the patient experienced an arrhythmia that met medical doctor notification (mdn) requirements that was not transmitted during the wear period.No adverse events such as death or serious injury are known to have occurred, however the patient later experienced a syncopal episode.The device was activated and worn for two days when a slow atrial fibrillation transmission that met auto-detection criteria was not transmitted resulting in a notification delay to the patient¿s attending physician.Eight days after the missed transmission, the patient was hospitalized for a syncopal episode while wearing the zio at patch device.This event is being reported per 21 cfr 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.

• Brand Name: ZEUS SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• 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 94103 ; 9494132147
• MDR Report Key: 17466299
• MDR Text Key: 320678108
• Report Number: 3007208829-2023-00044
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K222389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 11/01/2023
• Device Model Number: S100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2023
• 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: 87 YR
• Patient Sex: Male