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

Device Problem Inaccurate Information (4051)

Patient Problem Unspecified Heart Problem (4454)

Event Date 03/15/2024

Event Type  Injury  

Event Description

The zio at device incorrectly detected artifact as an arrhythmia during the patient¿s wear period.The hcp requested device data from irhythm to review the patient's arrhythmia.Irhythm's investigation found that the preliminary ecg interpretation was misclassified, and the interpretation was amended.The hcp was notified immediately, and irhythm learned that the patient was admitted to the hospital based on the initial preliminary results but not treated for that arrhythmia.Subsequently, a different arrhythmia was noted on ecg, and the patient was treated.No further information was provided.

• 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, CA 94103 ; 9494132147
• MDR Report Key: 19076657
• MDR Text Key: 339777761
• Report Number: 3007208829-2024-00157
• 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: 04/09/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2024
• Date Device Manufactured: 11/15/2023
• 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
• Treatment: ZIO AT/SN: (B)(6)
• Patient Outcome(s): Hospitalization
• Patient Age: 9 DA