HEARTWARE VENTRICULAR ASSIST SYSTEM - DRIVELINE Adverse Event — Malfunction (MDR 3007042319-2020-03003)
HEARTWARE VENTRICULAR ASSIST SYSTEM - DRIVELINE Adverse Event — Malfunction (MDR 3007042319-2020-03003) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HEARTWARE VENTRICULAR ASSIST SYSTEM - DRIVELINE; Generic name: VENTRICULAR (ASSIST) BYPASS; Manufacturer: HEARTWARE, INC..
| Device | HEARTWARE VENTRICULAR ASSIST SYSTEM - DRIVELINE |
|---|---|
| Generic name | VENTRICULAR (ASSIST) BYPASS |
| Manufacturer | HEARTWARE, INC. |
| Report number | 3007042319-2020-03003 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE EVALUATION. PRODUCT EVENT SUMMARY:THE DRIVELINE CABLE WAS NOT RETURNED FOR EVALUATION. THE REPORTED DRIVELINE SNAG EVENT COULD NOT BE CONFIRMED DUE TO INSUFFICIENT EVIDENCE. BASED ON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO INDICATE THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION |
| Source | openFDA MAUDE (device adverse events) |
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