MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-03 for HEARTWARE manufactured by Heartware Medtronic.
[141382363]
On (b)(6) 2019 pt admitted with low flow alarms on heartware lvad (0. 5l/min), causing pt to cardiac arrest - ecmo placed, in operating room for successful pump exchange. Pt tolerated well, neurologically intact without deficits.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8496047 |
| MDR Report Key | 8496047 |
| Date Received | 2019-04-03 |
| Date of Report | 2019-03-05 |
| Date of Event | 2019-02-11 |
| Date Facility Aware | 2019-02-02 |
| Report Date | 2019-03-05 |
| Date Reported to FDA | 2019-04-03 |
| Date Added to Maude | 2019-04-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEARTWARE |
| Generic Name | HEARTWARE |
| Product Code | OKR |
| Date Received | 2019-04-03 |
| Model Number | HEARTWARE |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEARTWARE MEDTRONIC |
| Manufacturer Address | 500 OLD CONNECTICUT PATH RD FRAMINGHAM MA 01701 US 01701 |
| Brand Name | HEARTWARE |
| Generic Name | HEARTWARE |
| Product Code | OKR |
| Date Received | 2019-04-03 |
| Model Number | HEARTWARE |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | HEARTWARE MEDTRONIC |
| Manufacturer Address | 500 OLD CONNECTICUT PATH RD FRAMINGHAM MA 01701 US 01701 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2019-04-03 |