HEARTMATE 3 SYSTEM CONTROLLER Adverse Event — Malfunction (MDR 2916596-2020-02033)
HEARTMATE 3 SYSTEM CONTROLLER Adverse Event — Malfunction (MDR 2916596-2020-02033) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HEARTMATE 3 SYSTEM CONTROLLER; Generic name: VENTRICULAR (ASSISST) BYPASS; Manufacturer: THORATEC CORPORATION.
| Device | HEARTMATE 3 SYSTEM CONTROLLER |
|---|---|
| Generic name | VENTRICULAR (ASSISST) BYPASS |
| Manufacturer | THORATEC CORPORATION |
| Report number | 2916596-2020-02033 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | FOREIGN, HEALTH PROFESSIONAL |
| Narrative | SECTION D4, D10, H3, H4: ADDITIONAL INFORMATION. MANUFACTURER'S INVESTIGATION CONCLUSIONS: THE REPORTED EVENT OF A DISPLAY ISSUE REGARDING THE SYSTEM CONTROLLER¿S LCD SCREEN WAS CONFIRMED. THE RETURNED SYSTEM CONTROLLER¿S (SERIAL NUMBER (B)(6), LCD SCREEN WAS OBSERVED TO BE BRIGHT WITH A WHITE LIGHT UPON BEING CONNECTED TO POWER. TEXT AND PUMP PARAMETERS WERE ABLE TO BE READ ON THE CONTROLLER, ALT |
| Source | openFDA MAUDE (device adverse events) |
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