MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-06 for KARDIAMOBILE AC-009 manufactured by Alivecor.
| Report Number | 3009715978-2019-00001 |
| MDR Report Key | 8972798 |
| Date Received | 2019-09-06 |
| Date of Report | 2019-06-04 |
| Date Mfgr Received | 2019-06-04 |
| Date Added to Maude | 2019-09-06 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR PRABHU RAGHAVAN |
| Manufacturer Street | 444 CASTRO STREET SUITE 600 |
| Manufacturer City | MOUNTAIN VIEW CA 94041 |
| Manufacturer Country | US |
| Manufacturer Postal | 94041 |
| Manufacturer Phone | 6503968562 |
| Manufacturer G1 | ALIVECOR |
| Manufacturer Street | 444 CASTRO STREET SUITE 400 |
| Manufacturer City | MOUNTAIN VIEW CA 94041 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | KARDIAMOBILE |
| Generic Name | MOBILE ELECTROCARDIOGRAM |
| Product Code | DPS |
| Date Received | 2019-09-06 |
| Model Number | AC-009 |
| Catalog Number | AC-009 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALIVECOR |
| Manufacturer Address | 444 CASTRO STREET SUITE 600 MOUNTAIN VIEW CA 94041 US 94041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-09-06 |