HEARTWARE VENTRICULAR ASSIST SYSTEM - WAIST PACK Adverse Event — Malfunction (MDR 3007042319-2020-02991)
HEARTWARE VENTRICULAR ASSIST SYSTEM - WAIST PACK Adverse Event — Malfunction (MDR 3007042319-2020-02991) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HEARTWARE VENTRICULAR ASSIST SYSTEM - WAIST PACK; Generic name: VENTRICULAR (ASSIST) BYPASS; Manufacturer: HEARTWARE, INC..
| Device | HEARTWARE VENTRICULAR ASSIST SYSTEM - WAIST PACK |
|---|---|
| Generic name | VENTRICULAR (ASSIST) BYPASS |
| Manufacturer | HEARTWARE, INC. |
| Report number | 3007042319-2020-02991 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR INVESTIGATION COMPLETION. PRODUCT EVENT SUMMARY: THE WAIST PACK WITH UNKNOWN LOT NUMBER WAS NOT RETURNED FOR EVALUATION. AS A RESULT, THE REPORTED EVENT COULD NOT BE CONFIRMED. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; EVENTS INVOLVING WAIST PACK BELT DAMAGE CAN BE ATTRIBUTED, BUT NOT LIMITED, TO |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →