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U.S. Department of Health and Human Services

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

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ALIVECOR, INC. KARDIAMOBILE MOBILE ELECTROCARDIOGRAM Back to Search Results
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".

 
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Brand NameKARDIAMOBILE
Type of DeviceMOBILE 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 Key9782689
MDR Text Key188139661
Report Number3009715978-2020-00001
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK182396
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 02/04/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/03/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberAC-009
Device Catalogue NumberAC-009
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2020
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 Unkown

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