HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP Adverse Event — Malfunction (MDR 3007042319-2020-02980)
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP Adverse Event — Malfunction (MDR 3007042319-2020-02980) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; Generic name: VENTRICULAR (ASSIST) BYPASS; Manufacturer: HEARTWARE, INC..
| Device | HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP |
|---|---|
| Generic name | VENTRICULAR (ASSIST) BYPASS |
| Manufacturer | HEARTWARE, INC. |
| Report number | 3007042319-2020-02980 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | FOREIGN, HEALTH PROFESSIONAL, L |
| Narrative | THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANS PLANTATION AND DESTINATION THERAPY IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PU |
| Source | openFDA MAUDE (device adverse events) |
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