Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
1 linked reportMalfunction 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-04 | 0 | 1 |
| 2019-07 | 0 | 1 |
| 2021-04 | 0 | 1 |
| 2022-01 | 0 | 1 |
| 2023-06 | 0 | 1 |
| 2023-10 | 0 | 2 |
| 2024-04 | 0 | 1 |
| 2024-08 | 1 | 1 |
| 2025-01 | 0 | 1 |
| 2025-02 | 0 | 2 |
| 2025-03 | 0 | 4 |
| 2025-04 | 0 | 1 |
| 2025-05 | 0 | 2 |
| 2025-06 | 0 | 5 |
| 2025-07 | 0 | 2 |
| 2025-08 | 0 | 2 |
| 2025-09 | 0 | 2 |
| 2025-11 | 0 | 2 |
| 2026-01 | 0 | 4.5 |
| 2026-05 | 0 | 2.5 |
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2024-08-29 | MW5159098 | Malfunction | Available | model number |
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-04-17 | OAI | Official action indicated | Advanced Instrumentations, Inc. | 5 |
| 2025-04-17 | OAI | Official action indicated | Advanced Instrumentations, Inc. | 5 |
| 2024-02-26 | VAI | Voluntary action indicated | Advanced Instrumentations, Inc. | 3 |
| 2024-02-26 | VAI | Voluntary action indicated | Advanced Instrumentations, Inc. | 3 |
| 2023-03-10 | VAI | Voluntary action indicated | Advanced Instrumentations, Inc. | 4 |
| 2023-03-10 | VAI | Voluntary action indicated | Advanced Instrumentations, Inc. | 4 |
| 2020-01-15 | VAI | Voluntary action indicated | Advanced Instrumentations, Inc. | 3 |
| 2020-01-15 | VAI | Voluntary action indicated | Advanced Instrumentations, Inc. | 3 |
| 2013-06-14 | VAI | Voluntary action indicated | Advanced Instrumentations, Inc. | 6 |
| 2013-06-14 | VAI | Voluntary action indicated | Advanced Instrumentations, Inc. | 6 |
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