HEARTWARE VENTRICULAR ASSIST SYSTEM - PATIENT PACK Adverse Event — Malfunction (MDR 3007042319-2020-03002)
HEARTWARE VENTRICULAR ASSIST SYSTEM - PATIENT PACK Adverse Event — Malfunction (MDR 3007042319-2020-03002) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HEARTWARE VENTRICULAR ASSIST SYSTEM - PATIENT PACK; Generic name: VENTRICULAR (ASSIST) BYPASS; Manufacturer: HEARTWARE, INC.
| Device | HEARTWARE VENTRICULAR ASSIST SYSTEM - PATIENT PACK |
|---|---|
| Generic name | VENTRICULAR (ASSIST) BYPASS |
| Manufacturer | HEARTWARE, INC. |
| Report number | 3007042319-2020-03002 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSP LANTATION 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. INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE |
| Source | openFDA MAUDE (device adverse events) |
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