MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-07-10 for HEARTSTART FRX 861304 manufactured by Philips Medical Systems.
[113535103]
Patient Sequence No: 1, Text Type: N, H10
[113535104]
It has been reported that the device is failing self-test.
Patient Sequence No: 1, Text Type: D, B5
[118127451]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3030677-2018-01492 |
| MDR Report Key | 7673574 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-07-10 |
| Date of Report | 2018-06-14 |
| Date Mfgr Received | 2018-06-14 |
| Device Manufacturer Date | 2013-08-01 |
| Date Added to Maude | 2018-07-10 |
| 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 | MISS SHANNON DECKER |
| Manufacturer Street | 22100 BOTHELL EVERETT HWY |
| Manufacturer City | BOTHELL WA 980218431 |
| Manufacturer Country | US |
| Manufacturer Postal | 980218431 |
| Manufacturer Phone | 8887445477 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEARTSTART FRX |
| Generic Name | AED |
| Product Code | MLN |
| Date Received | 2018-07-10 |
| Model Number | 861304 |
| Lot Number | 70302-0953 |
| Device Expiration Date | 2019-09-30 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 22100 BOTHELL EVERETT HWY BOTHELL WA 980218431 US 980218431 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-10 |