D
Patient 1
IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.
MAUDE MDR 9777617
- MDR report key
- 9777617
- Report number
- 3030677-2020-00380
- Event key
- 0
- Event type
- 3
- Date received
- 2020-03-02
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MRS. DANA TACKETT
- Address
- 22100 BOTHELL EVERETT HWY BOTHELL WA 98021 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | HEARTSTART HOME | AED | PHILIPS MEDICAL SYSTEMS | NSA | M5068A | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-02 | 0 |