HEARTMATE POWER MODULE BACKUP BATTERY Adverse Event — Malfunction (MDR 2916596-2020-02293)
HEARTMATE POWER MODULE BACKUP BATTERY Adverse Event — Malfunction (MDR 2916596-2020-02293) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HEARTMATE POWER MODULE BACKUP BATTERY; Generic name: VENTRICULAR (ASSISST) BYPASS; Manufacturer: THORATEC CORPORATION.
| Device | HEARTMATE POWER MODULE BACKUP BATTERY |
|---|---|
| Generic name | VENTRICULAR (ASSISST) BYPASS |
| Manufacturer | THORATEC CORPORATION |
| Report number | 2916596-2020-02293 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | HEALTH PROFESSIONAL |
| Narrative | MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE BATTERY NOT HOLDING CHARGE WAS CONFIRMED. THE POWER MODULE BACKUP BATTERY WAS RETURNED FOR ANALYSIS AND WAS CONNECTED TO A CALIBRATED POWER MODULE TO CHARGE. ONCE FULLY CHARGED, THE POWER MODULE WAS RUNNING ON BATTERY POWER WHILE CONNECTED TO A CALIBRATED SYSTEM CONTROLLER AND IMMEDIATELY ALARMED FOR LOW POWER, CONFIRMING THE REPOR |
| Source | openFDA MAUDE (device adverse events) |
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