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

Model Number	AC-009
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	05/19/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: MOBILE ELECTROCARDIOGRAM
• Manufacturer (Section D): ALIVECOR, INC.; 444 castro st.; suite 600; mountain view, ca
• MDR Report Key: 10217486
• Report Number: 3009715978-2020-00003
• Device Sequence Number: 14094588
• Product Code: DXH
• UDI-Device Identifier: B210AC0090
• UDI-Public: +B210AC0090
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Model Number: AC-009
• Device Catalogue Number: AC-009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 07/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization