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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALIVECOR KARDIAMOBILE MOBILE ELECTROCARDIOGRAM

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ALIVECOR KARDIAMOBILE MOBILE ELECTROCARDIOGRAM Back to Search Results
Model Number AC-009
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Myocardial Infarction (1969); Complete Heart Block (2627)
Event Type  Injury  
Manufacturer Narrative

Alivecor received a social media comment from a user where it appears that the user while experiencing a "100% lad blockage" recorded an ecg and likely received device algorithm analysis of "normal sinus rhythm"; the user likely delayed medical attention due to this result. Alivecor followed up with the customer 4 separate times to get additional information but was not successful. Alivecor is a lead-i mobile ecg that is not intended to detect an infarct. The device labeling specifies that the device does not detect heart attack. It is common for ecgs during 100% lad blockage to still be normal sinus rhythm and the st elevation that is normally present during such incidents is not detectable in lead-i. Note that the device is also not intended to detect st elevation. 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 contacted alivecor stating that he used kardiamobile to take ekg and received normal sinus rhythm while experiencing 100% blockage of the lad. Patient noted that he delayed seeking medical treatment which potentially resulted in additional damage. The specific comment from the user notes that "i was having a actual heart attack. 100% blockage of the lad and it said nothing was wrong. I delayed going because of this and probably suffered more damage. ".

 
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Brand NameKARDIAMOBILE
Type of DeviceMOBILE ELECTROCARDIOGRAM
Manufacturer (Section D)
ALIVECOR
444 castro street
suite 600
mountain view CA 94041
Manufacturer (Section G)
ALIVECOR
444 castro street
suite 400
mountain view CA 94041
Manufacturer Contact
prabhu raghavan
444 castro street
suite 600
mountain view, CA 94041
6503968562
MDR Report Key8972798
MDR Text Key161201796
Report Number3009715978-2019-00001
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
PMA/PMN NumberK182396
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Type of Report Initial
Report Date 06/04/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/06/2019
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/04/2019
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/06/2019 Patient Sequence Number: 1
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