MAUDE Adverse Event Report: ALIVECOR KARDIAMOBILE; MOBILE ELECTROCARDIOGRAM

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.".

• Brand Name: KARDIAMOBILE
• Type of Device: MOBILE 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 Key: 8972798
• MDR Text Key: 161201796
• Report Number: 3009715978-2019-00001
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• PMA/PMN Number: K182396
• Number of Events Reported: 1
• 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

• 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: 06/04/2019
• Initial Date FDA Received: 09/06/2019
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization