ALIVECOR KARDIABAND AC-011-42-A KARDIABAND - 42MM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-21 for ALIVECOR KARDIABAND AC-011-42-A KARDIABAND - 42MM manufactured by Alivecor, Inc..

Event Text Entries

[109107447] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5077351
MDR Report Key7533649
Date Received2018-05-21
Date of Report2018-05-17
Date of Event2018-05-17
Date Added to Maude2018-05-22
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameALIVECOR KARDIABAND
Generic NameELECTROCARDIOGRAPH
Product CodeDPS
Date Received2018-05-21
Model NumberAC-011-42-A
Catalog NumberKARDIABAND - 42MM
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerALIVECOR, INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2018-05-21

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