SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE Adverse Event — Malfunction (MDR 3003761017-2008-00003)
SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE Adverse Event — Malfunction (MDR 3003761017-2008-00003) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE; Generic name: CARCULATORY ASSIST DEVICE; Manufacturer: SYNCARDIA SYSTEMS, INC..
| Device | SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE |
|---|---|
| Generic name | CARCULATORY ASSIST DEVICE |
| Manufacturer | SYNCARDIA SYSTEMS, INC. |
| Report number | 3003761017-2008-00003 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-19 |
| Report source | User facility |
| Narrative | CUSTOMER REPORTED THAT WHEN DEPRESSING ONE OF THE BATTERY TEST PUSH BUTTONS ON THE CSS CONSOLE, THE INDICATOR WENT FROM GREEN TO RED IN LESS THAN THE 10 SECOND HOLD TIME RECOMMENDED. THE CUSTOMER REPORTED THAT ALTHOUGH THE CONSOLE WAS PERFORMING AS EXPECTED AND THAT THERE WAS NO PT IMPACT, THE PT WAS SWITCHED TO A BACKUP CONSOLE. THE CONSOLE WAS RETURNED TO SYNCARDIA AND AN EVALUATION WAS PERFORME |
| Source | openFDA MAUDE (device adverse events) |
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