MAUDE Adverse Event Report: ALIVECOR, INC. ALIVECOR KARDIABAND; ELECTROCARDIOGRAPH

Model Number AC-011-42-A

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/17/2018

Event Type  malfunction  

Event Description

Upon calling customer service at alivcor because their kardia watch was not working (it would not record my ekg), i was asked if i had a hearing aid or a pacemaker.I have a pacemaker permanently implanted.I was then informed that the kardiaband would not work with such an implanted device.I looked online, found their instructions for use, and it was only then that i read the warning that the device should not be used if you have a pacemaker.These ifu's are inadequate, as it requires the user to have access to the online ifu's.Warnings like these should be printed and furnished with the product labeling.The company's online advertising is false and misleading in that nowhere do they state in their compatibility" claims that the device cannot be used in pts with hearing aids or implanted devices for cardiac rhythm, or to even refer to the instructions for use for all warnings, precautions, indications or contraindications.

• Brand Name: ALIVECOR KARDIABAND
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): ALIVECOR, INC.
• MDR Report Key: 7533649
• MDR Text Key: 109107447
• Report Number: MW5077351
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: AC-011-42-A
• Device Catalogue Number: KARDIABAND - 42MM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/21/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 76