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

Device Problem Failure to Transmit Record (1521)

Patient Problem Unspecified Heart Problem (4454)

Event Date 02/21/2024

Event Type  malfunction  

Manufacturer Narrative

1.

Event Description

The patient experienced an arrhythmia that met medical doctor notification (mdn) requirements that was not communicated during the wear period.The investigation revealed that a preliminary ecg interpretation provided to the physician was misclassified.Following the wear period and while compiling the final report, the interpretation was amended.The healthcare provider (hcp) was immediately notified, and irhythm learned that the hcp was already aware of the patient's arrhythmia and was treating it.There were no delays in treatment, and no adverse events, such as death or serious injury, are known to have occurred.

• Brand Name: ZEUS SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES, INC; 699 8th st suite 600; san francisco CA 90630
• 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
• MDR Report Key: 19085481
• MDR Text Key: 340684030
• Report Number: 3007208829-2024-00170
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/10/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2024
• 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
• Treatment: ZIO AT/SN: (B)(6).
• Patient Age: 67 YR