MAUDE Adverse Event Report: ALIVECOR, INC. KARDIAMOBILE; MOBILE ELECTROCARDIOGRAM

Model Number AC-009

Device Problem Defective Device (2588)

Patient Problem Myocardial Infarction (1969)

Event Type  Injury  

Manufacturer Narrative

Alivecor received a complaint from user's relative where it appears that the user while experiencing a heart attack recorded an ecg and likely received device algorithm analysis of "normal sinus rhythm".It is unknown whether the user delayed seeking medical attention due to the kardiamobile result.Alivecor followed up with the user 4 seperate times to get additional information but was not successful.Alivecor is a lead-i mobile ecg that is not intended to detect heart attacks.The device labeling specifies that the device does not detect heart attack.It is possible for ecgs during a heart attack to still be normal sinus rhythm.It appears that the device likely had no malfunction, did not cause or contribute to the heart attack, and the incident was a result of user error.

Event Description

Patient's family member contacted alivecor stating that the patient used kardiamobile to take ekg and received normal sinus rhythm determination while experiencing a heart attack.The specific comment from the patient's family member notes that ".We found out it (kardiamobile) was defective when my mom used the product and it showed normal as she was in the middle of a heart attack".

• Brand Name: KARDIAMOBILE
• Type of Device: MOBILE ELECTROCARDIOGRAM
• Manufacturer (Section D): ALIVECOR, INC.; 444 castro street; suite 600; mountain view, ca
• Manufacturer (Section G): ALIVECOR, INC.; 444 castro street; suite 600; mountain view, ca
• Manufacturer Contact: saket bhatt ; 444 castro street; suite 600; mountain view, ca ; 3968557
• MDR Report Key: 9782689
• MDR Text Key: 188139661
• Report Number: 3009715978-2020-00001
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: AC-009
• Device Catalogue Number: AC-009
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/04/2020
• Initial Date FDA Received: 03/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1