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U.S. Department of Health and Human Services

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

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ALIVECOR, INC. ALIVECOR KARDIABAND ELECTROCARDIOGRAPH Back to Search Results
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.

 
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Brand NameALIVECOR KARDIABAND
Type of DeviceELECTROCARDIOGRAPH
Manufacturer (Section D)
ALIVECOR, INC.
MDR Report Key7533649
MDR Text Key109107447
Report NumberMW5077351
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received05/21/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberAC-011-42-A
Device Catalogue NumberKARDIABAND - 42MM
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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