MAUDE Adverse Event Report: ALIVECOR, INC. KARDIAMOBILE 6L; MOBILE ELECTROCARDIOGRAM

Model Number AC-019

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

Patient Problem Cardiac Arrest (1762)

Event Date 09/08/2020

Event Type  Injury  

Manufacturer Narrative

User's husband contacted alivecor on sept.22, 2020 about a complaint regarding her kardiamobile 6l device.User's husband reported that the user has been using her kardiamobile 6l device and readings "show up as normal".On (b)(6) 2020, user suffered cardiac arrest and survived.Subsequently, user's husband reported that the user has "long qt which was the precursor" to the cardiac arrest.User and her spouse did not understand that the device algorithm could not detect long qt syndrome (lqts) and may have delayed seeking medical treatment due to the kardiamobile 6l result.Alivecor contacted the user on three separate occasions (oct.1, oct.9 and oct.15) to follow up and investigate the complaint but user did not respond or return the kardiamobile 6l device for hardware investigation.Alivecor's kardiamobile 6l device is a lead-i and lead-ii mobile ekg device that is not intended to detect long qt syndrome (lqts).It appears that the device likely had no malfunction, did not cause or contribute to the cardiac arrest, and the incident was a result of user error.

Event Description

User's husband contacted alivecor on sept.22, 2020 with a complaint regarding her kardiamobile 6l device.User was reported to be using her kardiamobile 6l and readings "show up as normal".On (b)(6) 2020, user suffered cardiac arrest and survived.Subsequently, user's husband stated that the user has "long qt which was the precursor" to the cardiac arrest.User's spouse expressed confusion that the device algorithm did not detect the long qt and may have delayed seeking medical treatment due to the kardiamobile 6l result.

• Brand Name: KARDIAMOBILE 6L
• Type of Device: MOBILE ELECTROCARDIOGRAM
• Manufacturer (Section D): ALIVECOR, INC.; 444 castro st.; suite 600; mountain view CA 94041
• Manufacturer (Section G): ALIVECOR; 444 castro st.; suite 600; mountain view CA 94041
• Manufacturer Contact: saket bhatt ; 444 castro st.; suite 600; mountain view, CA 94041 ; 6503968557
• MDR Report Key: 10702303
• MDR Text Key: 212260415
• Report Number: 3009715978-2020-00004
• Device Sequence Number: 1
• Product Code: DXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183319
• 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: 10/19/2020

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-019
• Device Catalogue Number: AC-019
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/19/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening