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

Model Number AC-009

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Myocardial Infarction (1969)

Event Date 05/19/2020

Event Type  Injury  

Manufacturer Narrative

User contacted alivecor on (b)(6) 2020 about a complaint regarding his kardiamobile 1l device while experiencing a heart attack on (b)(6) 2020.User recorded an ekg on his kardiamobile 1l and received a device algorithm analysis of "normal sinus rhythm".The user did not delay seeking medical attention due to the kardiamobile result.Alivecor contacted the user on four separate occasions (june 5, june 9, june 17 and june 19) to investigate the complaint and retrieve ekg data for cardiology review however the user did not send his ekg tracing.Alivecor's kardiamobile 1l device is a lead-i mobile ekg device that is not intended to detect an infarct or st elevation.The device labeling specifies that the device does not detect heart attacks.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

User contacted alivecor on (b)(6) 2020 stating that he used his kardiamobile 1l to take an ekg and received a normal sinus rhythm determination while experiencing a heart attack.The specific comments from the patient notes that "still recovering from heart attack on (b)(6).I used this device 2 minutes prior to calling ambulance and device said everything was fine with my heart.Suffered major heart attack that morning.".

• Brand Name: KARDIAMOBILE
• Type of Device: MOBILE ELECTROCARDIOGRAM
• Manufacturer (Section D): ALIVECOR, INC.; 444 castro st.; suite 600; mountain view, ca
• Manufacturer (Section G): ALIVECOR, INC.; 444 castro st.; suite 600; mountain view, ca
• Manufacturer Contact: saket bhatt ; 444 castro st.; suite 600; mountain view, ca ; 3968557
• MDR Report Key: 10217486
• MDR Text Key: 201220225
• Report Number: 3009715978-2020-00003
• Device Sequence Number: 1
• Product Code: DXH
• UDI-Device Identifier: B210AC0090
• UDI-Public: +B210AC0090
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2020

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: 06/02/2020
• Initial Date FDA Received: 07/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2019
• 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
• Patient Outcome(s): Hospitalization