MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-16 for HEARTSTART HOME M5068A manufactured by Philips Medical Systems.
[145354410]
.
Patient Sequence No: 1, Text Type: N, H10
[145354411]
It has been reported that the aed is not functioning properly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3030677-2019-01027 |
| MDR Report Key | 8617279 |
| Date Received | 2019-05-16 |
| Date of Report | 2018-04-19 |
| Date Mfgr Received | 2019-04-26 |
| Device Manufacturer Date | 2012-01-01 |
| Date Added to Maude | 2019-05-16 |
| 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 | MRS. DANA TACKETT |
| Manufacturer Street | 22100 BOTHELL EVERETT HWY |
| Manufacturer City | BOTHELL WA 98021 |
| Manufacturer Country | US |
| Manufacturer Postal | 98021 |
| Manufacturer G1 | PHILIPS HEALTHCARE - BOTHELL |
| Manufacturer Street | 22100 BOTHELL-EVERETT HWY BLDG A |
| Manufacturer City | BOTHELL WA 98021 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98021 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0642-2013, Z-0643-2013 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HEARTSTART HOME |
| Generic Name | AED |
| Product Code | NSA |
| Date Received | 2019-05-16 |
| Model Number | M5068A |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 22100 BOTHELL EVERETT HWY BOTHELL WA 98021 US 98021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-16 |