MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-03 for KARDIAMOBILE AC-009 manufactured by Alivecor, Inc..
[188139661]
Alivecor received a complaint from user's relative where it appears that the user while experiencing a heart attack recorded an ecg and likely received device algorithm analysis of "normal sinus rhythm". It is unknown whether the user delayed seeking medical attention due to the kardiamobile result. Alivecor followed up with the user 4 seperate times to get additional information but was not successful. Alivecor is a lead-i mobile ecg that is not intended to detect heart attacks. The device labeling specifies that the device does not detect heart attack. It is possible for ecgs during a heart attack to still be normal sinus rhythm. It appears that the device likely had no malfunction, did not cause or contribute to the heart attack, and the incident was a result of user error.
Patient Sequence No: 1, Text Type: N, H10
[188139662]
Patient's family member contacted alivecor stating that the patient used kardiamobile to take ekg and received normal sinus rhythm determination while experiencing a heart attack. The specific comment from the patient's family member notes that "... We found out it (kardiamobile) was defective when my mom used the product and it showed normal as she was in the middle of a heart attack".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009715978-2020-00001 |
| MDR Report Key | 9782689 |
| Report Source | OTHER |
| Date Received | 2020-03-03 |
| Date of Report | 2020-02-04 |
| Date Mfgr Received | 2020-02-04 |
| Date Added to Maude | 2020-03-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. SAKET BHATT |
| Manufacturer Street | 444 CASTRO STREET SUITE 600 |
| Manufacturer City | MOUNTAIN VIEW, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 3968557 |
| Manufacturer G1 | ALIVECOR, INC. |
| Manufacturer Street | 444 CASTRO STREET SUITE 600 |
| Manufacturer City | MOUNTAIN VIEW, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KARDIAMOBILE |
| Generic Name | MOBILE ELECTROCARDIOGRAM |
| Product Code | DPS |
| Date Received | 2020-03-03 |
| Model Number | AC-009 |
| Catalog Number | AC-009 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALIVECOR, INC. |
| Manufacturer Address | 444 CASTRO STREET SUITE 600 MOUNTAIN VIEW, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-03 |