HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 Adverse Event — Malfunction (MDR 3007042319-2020-03009)
HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 Adverse Event — Malfunction (MDR 3007042319-2020-03009) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0; Generic name: VENTRICULAR (ASSIST) BYPASS; Manufacturer: HEARTWARE,
| Device | HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 |
|---|---|
| Generic name | VENTRICULAR (ASSIST) BYPASS |
| Manufacturer | HEARTWARE, INC. |
| Report number | 3007042319-2020-03009 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE EVALUATION. PRODUCT EVENT SUMMARY: THE CONTROLLER WAS NOT RETURNED FOR EVALUATION. LOG FILE ANALYSIS REVEALED SEVEN (7) CONTROLLER POWER UP EVENTS ON 14-APR-2020 AT 09:49:08 AND 09:50:47, ON 01-MAY-2020 AT 08:53:54, 15:49:50 AND 15:51:46, ON 02-MAY-2020 AT 06:49:36 AND ON 03-MAY-2020 AT 09:00:27. NO ANOMALIES WERE OBSERVED LEADING UP TO THE LOSSE |
| Source | openFDA MAUDE (device adverse events) |
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