MAUDE Adverse Event Report: ALIVECOR KARDIAMOBILE; ELECTROCARDIOGRAPH

Device Problem Product Quality Problem (1506)

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

Event Type  malfunction  

Event Description

Dear fda, the kardiamobile medical device was commercially released utilizing multiple fda 510(k) clearances, e.G., k210753.I believe kardiamobile device is misbranded and adulterated as it claims "fda clearance" and device superiority claims without data.Kardiamobile is advertised in multiple tv commercials (b)(6) and on the internet at kardia.Com.The tv commercials and the kardia.Com website proudly make "fda cleared" claims, as well as, the claim that this device is the "most reliable" method to home monitor a cardiac patient's heart status, e.G.: a."trusted; fda cleared", b."fda cleared personal ekg.The world's most clinically validated single lead ekg, kardiamobile is the most reliable way to check in on your heart from home.") this device is not the "most reliable" home cardiac monitor, when compared to all other external cardiac monitors, e.G., the holter multiple lead cardiac monitor.These statements clearly provides a "representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding" and are prohibited by 21 cfr 807.97.Please take action with kardiamobile to ensure patients are not mislead into the belief that this device has fda's "stamp of approval" and that it is the "most reliable" home monitoring method.(b)(6).Fda safety report id# (b)(4).

• Brand Name: KARDIAMOBILE
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): ALIVECOR
• MDR Report Key: 13342661
• MDR Text Key: 284624895
• Report Number: MW5106922
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2022
• Patient Sequence Number: 1