MAUDE Adverse Event Report: IRHYTHM TECHNOLOGIES ZIO HEART MONITOR

Device Problems Material Separation (1562); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2018

Event Type  malfunction  

Event Description

Zio 7 day heart recorder: after 2 days, the unit separated from the adhesive attached to the chest wall.Child did not shower, gel the unit wet, or have any excessive activity.Reported the problem to the mfr.Their response was this is normal, and if the dr can use any of the info, were going to get charged for the full use per their policy.No care about the unit failing at all.

• Brand Name: ZIO HEART MONITOR
• Type of Device: ZIO HEART MONITOR
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES
• MDR Report Key: 7334174
• MDR Text Key: 102340095
• Report Number: MW5075814
• Device Sequence Number: 0
• Product Code: DSH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 03/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8 YR
• Patient Weight: 24