ENSITE VELOCITY SYSTEM VELOCITY AMPLIFIER Adverse Event — Injury (MDR 2184149-2020-00050)
ENSITE VELOCITY SYSTEM VELOCITY AMPLIFIER Adverse Event — Injury (MDR 2184149-2020-00050) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ENSITE VELOCITY SYSTEM VELOCITY AMPLIFIER; Generic name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE; Manufacturer: ST. JUDE MEDICAL, INC..
| Device | ENSITE VELOCITY SYSTEM VELOCITY AMPLIFIER |
|---|---|
| Generic name | COMPUTER, DIAGNOSTIC, PROGRAMMABLE |
| Manufacturer | ST. JUDE MEDICAL, INC. |
| Report number | 2184149-2020-00050 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | ONE ENSITE VELOCITY¿ SYSTEM VELOCITY AMPLIFIER WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THE CONNECTORS AND LABELS APPEARED TO HAVE NO PHYSICAL DAMAGE. THE AMPLIFIER WAS POWERED ON AND PASSED THE POWER ON SELF-TEST (POST) WITH A GREEN LED STATUS. COMMUNICATION WAS ESTABLISHED THE TEST STATION. THE FIELD REPORTED EVENT WAS CONFIRMED AS REVIEW OF ERROR LOGS IDENTIFIED CONSISTENT BOARD |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →