HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE Adverse Event — Malfunction (MDR 3007042319-2020-02999)
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE Adverse Event — Malfunction (MDR 3007042319-2020-02999) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE; Generic name: VENTRICULAR (ASSIST) BYPASS; Manufacturer: HEARTWARE,
| Device | HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE |
|---|---|
| Generic name | VENTRICULAR (ASSIST) BYPASS |
| Manufacturer | HEARTWARE, INC. |
| Report number | 3007042319-2020-02999 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL |
| Narrative | A SUPPLEMENTAL REPORT IS SUBMITTED FOR A CORRECTION. THE MANUFACTURER NARRATIVE IS BEING UPDATED TO INCLUDE THE CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) INFORMATION. THIS REPORT WAS GENERATED AS PART OF THE CUSTOMER SOLICITED FEEDBACK REMEDIATION PROJECT AS PER CAPA 484633: POTENTIAL MCS PRODUCT COMPLAINTS FROM SOLICITED CUSTOMER EXPERIENCE, TO CAPTURE THE POTENTIAL COMPLAINTS THAT WERE DISCOVERED |
| Source | openFDA MAUDE (device adverse events) |
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