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

Device Problems Use of Device Problem (1670); Human-Device Interface Problem (2949); Device Handling Problem (3265)

Patient Problem Cardiac Arrest (1762)

Event Date 08/12/2021

Event Type  Injury  

Manufacturer Narrative

This mdr submission represents an incident where the patient was hospitalized.The investigation revealed a use error leading to a serious injury.Although there was no device malfunction, the use error contributed to the serious injury.Placed on patient (b)(6) 20221 however registration was not completed till (b)(6) 2021.The patient experienced multiple medical doctor notification (mdns) that contained events of va due chb and chb which were transmitted to irhythm, but without the complete registration, irhythm cannot start the ecg monitoring under idtf regulation 42 cfr 410.Once the patient was registered on (b)(6) 2021, all the medical doctor notification (mdn) transmissions came through to irhythm for monitoring.A clinically actionable arrhythmia occurred while the patient was in the car, at the time of the cardiac arrest.The patient was admitted to the er with a temporary pacemaker and is scheduled for pacemaker implant.

Event Description

Per an update to the criteria for reportable events, this mdr is being submitted.On (b)(6) 2022 a serious injury affecting the patient was identified as part of a retrospective review.

• 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: 16076067
• MDR Text Key: 306408104
• Report Number: 3007208829-2022-00064
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 01/03/2022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2021
• 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): Other; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female