• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRHYTHM TECHNOLOGIES, INC. ZIO XT HEART MONITOR RECORDER, MAGNETIC TAPE, MEDICAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

IRHYTHM TECHNOLOGIES, INC. ZIO XT HEART MONITOR RECORDER, MAGNETIC TAPE, MEDICAL Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Reaction (2414); Blood Loss (2597); Tissue Breakdown (2681)
Event Date 01/26/2020
Event Type  Injury  
Event Description
The glue on the back of the device caused the patient to bleed. I do not believe the glue is safe for humans. The manufacturer representative said they do not know what glue is being used or whether it is safe for humans. Called the fda and they told me no mention of the glue was made on the manufacturer's application for approval. This is a serious over site when so many patients have had adverse effects to the glue. No warning is given to the patient ahead of use. Customer service did not tell me to remove the device immediately when the reaction began, and leaving it on ate a whole in my skin. I'm enclosing a piece of the device edge where the glue was as well, so that you can test its safety. The device malfunctions when the glue causes bleeding as moisture disrupts the contacts on the device from recording information it claimed it would record for 14 days, it worked only a few days before malfunctioning. This problem is so prevalent that even their instruction manual describes it as a device flaw. The device is placed on the patient at a doctors office. Once at home the device is suppose to monitor heart rhythms uninterrupted for 14 days. The device does not work as advertised. Many patients have complained to irhythm technologies about these problems.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameZIO XT HEART MONITOR
Type of DeviceRECORDER, MAGNETIC TAPE, MEDICAL
Manufacturer (Section D)
IRHYTHM TECHNOLOGIES, INC.
650 townsend st, ste 500
san francisco CA 94103
MDR Report Key10223710
MDR Text Key197566438
Report NumberMW5095324
Device Sequence Number1
Product Code DSH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 02/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 07/01/2020 Patient Sequence Number: 1
-
-