AIA-900 Adverse Event — Malfunction (MDR 8031673-2020-00123)
AIA-900 Adverse Event — Malfunction (MDR 8031673-2020-00123) 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 | 8031673-2020-00123 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL |
| Narrative | DEVICE EVALUATION BY MANUFACTURER: A FIELD SERVICE ENGINEER (FSE) WAS AT THE CUSTOMER'S SITE TO ADDRESS THE REPORTED EVENT. FSE CONFIRMED THE PROBLEM BY REVIEWING THE ERROR LOG AND REPRODUCED THE PROBLEM BY PERFORMING QC RUN. FSE FOUND THAT THE DETECTOR LENS WAS DIRTY AND CLEANED THE LENS, WHICH SOLVED THE HIGH QC. FSE VALIDATED THE INSTRUMENT BY RUNNING CUSTOMER PREPARED QC; QC PASSED AND WITHIN |
| Source | openFDA MAUDE (device adverse events) |
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