AIA-900 Adverse Event — Malfunction (MDR 8031673-2020-00125)
AIA-900 Adverse Event — Malfunction (MDR 8031673-2020-00125) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: AIA-900; Generic name: AIA-900; Manufacturer: TOSOH CORPORATION.
| Device | AIA-900 |
|---|---|
| Generic name | AIA-900 |
| Manufacturer | TOSOH CORPORATION |
| Report number | 8031673-2020-00125 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL |
| Narrative | DEVICE EVALUATION BY MANUFACTURER: A FIELD SERVICE ENGINEERING (FSE) WAS AT CUSTOMER'S SITE TO RESOLVE REPORTED EVENT. FSE CONFIRMED THE ERROR BY REVIEWING THE ERROR LOG AND REPRODUCED ERROR BY ATTEMPTING A SAMPLE RUN. WHILE TROUBLESHOOTING, FSE NOTICED THE RACK PUSHER FOOT WAS OUT OF POSITION. FSE ADJUSTED THE HOME SENSOR FLAG FOR THE X1 MOTOR, THEN RAN RACK ROTATION WITHOUT ERRORS. FSE CHECKED R |
| Source | openFDA MAUDE (device adverse events) |
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