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

Device Problems Electromagnetic Interference (1194); Incorrect, Inadequate or Imprecise Result or Readings (1535); Missing Information (4053)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2021

Event Type  malfunction  

Event Description

Incorrect cardiac data; zio heart monitor is essentially fraudulent if used as described, and they need to stop selling the device until they change the patient guide! people's lives are at stake based on data gathered from this device and admitted by the company in fine print at the end of the patient guide the data is possibly faulty due to rf interference in almost any normal setting.The technical tables at the end of the manual refer to electromagnetic immunity and it says, "the customer or the user should assure that it is used in such an environment." according to the table in the patient guide, my cell phone should have been kept at a minimum of 7.5 feet away from the monitor! there's a page of "do's and don'ts" in the patient guide, but cell phone/electronic interference is not mentioned there.I found this critical info in fine print at the very end of the booklet under technical references.I found it by accident and this important info is in the last chapter after troubleshooting; two chapters that most patients will never read.As it stands, me and medicare are paying for a device that states in its own manual that it may be unreliable when exposed to normal household electronics like cell phones according to the fcc, cell phone max output is 1.6w.My transmitter is at the highest end listed in the table, but even at the lowest frequency, a cell phone should have been kept at 1.2m/3.9 feet.Fda safety report id # (b)(4).

• Brand Name: ZIO XT WEARABLE HEART MONITOR
• Type of Device: RECORDER, MAGNETIC TAPE, MEDICAL
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES, INC.
• MDR Report Key: 11139137
• MDR Text Key: 226274538
• Report Number: MW5098731
• Device Sequence Number: 1
• Product Code: DSH
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: No
• 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 Outcome(s): Other
• Patient Age: 57 YR