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.
21 linked reportsMalfunction 13Death 4Injury 4
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1 |
| 2020-03 | 0 | 1 |
| 2020-04 | 0 | 2.5 |
| 2020-05 | 0 | 1 |
| 2020-06 | 0 | 1 |
| 2020-07 | 0 | 1 |
| 2020-10 | 0 | 1 |
| 2020-11 | 0 | 1 |
| 2020-12 | 0 | 1 |
| 2021-01 | 0 | 1 |
| 2021-05 | 0 | 1 |
| 2021-08 | 0 | 1 |
| 2021-09 | 0 | 1 |
| 2021-11 | 0 | 1 |
| 2022-01 | 0 | 3 |
| 2022-06 | 0 | 1 |
| 2023-02 | 1 | 1 |
| 2023-04 | 0 | 1 |
| 2023-05 | 0 | 1 |
| 2023-08 | 0 | 1 |
| 2023-11 | 4 | 4 |
| 2024-01 | 0 | 1 |
| 2024-04 | 0 | 2 |
| 2024-05 | 1 | 1 |
| 2024-06 | 0 | 1.33 |
| 2024-07 | 0 | 4 |
| 2024-08 | 0 | 4 |
| 2024-11 | 0 | 6 |
| 2024-12 | 0 | 4 |
| 2025-01 | 0 | 3 |
| 2025-02 | 0 | 1 |
| 2025-04 | 0 | 4 |
| 2025-05 | 0 | 9.33 |
| 2025-06 | 0 | 24 |
| 2025-07 | 0 | 6 |
| 2025-08 | 0 | 1 |
| 2025-09 | 0 | 3 |
| 2025-10 | 0 | 3.5 |
| 2025-11 | 4 | 4 |
| 2026-01 | 0 | 3 |
| 2026-02 | 4 | 4 |
| 2026-04 | 5 | 5 |
| 2026-05 | 2 | 2 |
Failure-mode summaryAI-generated
21 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-05-22 | 9610691-2026-00014 | Malfunction | Available | exact di |
| 2026-05-22 | 1220828-2026-00014 | Malfunction | Available | exact di |
| 2026-04-08 | 9610691-2026-00007 | Malfunction | Available | catalog number |
| 2026-04-08 | 1220828-2026-00007 | Malfunction | Available | catalog number |
| 2026-02-13 | 1220828-2026-00003 | Malfunction | Available | exact di |
| 2026-02-13 | 9610691-2026-00003 | Malfunction | Available | catalog number |
| 2025-11-11 | 1220828-2025-00026 | Injury | Available | catalog number |
| 2025-11-11 | 9610691-2025-00026 | Injury | Available | catalog number |
| 2024-05-13 | 19297716 | Malfunction | Available | catalog number |
| 2023-11-09 | 9610691-2023-00025 | Death | Available | catalog number |
| 2023-11-09 | 1220828-2023-00020 | Death | Available | catalog number |
| 2023-02-17 | 9610691-2023-00007 | Malfunction | Available | exact di |
Showing the most recent 12 of 21 linked reports.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2016-05-20 | VAI | Voluntary action indicated | AMBU Limited | 0 |
| 2016-04-15 | VAI | Voluntary action indicated | Ambu Sdn. Bhd. | 0 |
| 2013-11-07 | VAI | Voluntary action indicated | AMBU Limited | 2 |
| 2013-09-19 | VAI | Voluntary action indicated | Ambu Sdn. Bhd. | 5 |
| 2013-06-19 | NAI | No action indicated | Ambu A/S | 0 |
| 2013-06-19 | NAI | No action indicated | Ambu A/S | 0 |
| 2011-06-02 | VAI | Voluntary action indicated | AMBU Limited | 2 |
| 2010-02-09 | NAI | No action indicated | Ambu A/S | 0 |
| 2010-02-09 | NAI | No action indicated | Ambu A/S | 0 |
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