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..
[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
| Report Number | MW5077351 |
| MDR Report Key | 7533649 |
| Date Received | 2018-05-21 |
| Date of Report | 2018-05-17 |
| Date of Event | 2018-05-17 |
| Date Added to Maude | 2018-05-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ALIVECOR KARDIABAND |
| Generic Name | ELECTROCARDIOGRAPH |
| Product Code | DPS |
| Date Received | 2018-05-21 |
| Model Number | AC-011-42-A |
| Catalog Number | KARDIABAND - 42MM |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALIVECOR, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-21 |