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.
6 linked reportsMalfunction 4Injury 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.14 |
| 2019-02 | 0 | 1.33 |
| 2019-04 | 0 | 1.22 |
| 2019-05 | 0 | 1.25 |
| 2019-06 | 0 | 1 |
| 2019-07 | 0 | 4 |
| 2019-10 | 0 | 1.11 |
| 2020-04 | 0 | 1.25 |
| 2020-05 | 0 | 4 |
| 2020-06 | 0 | 2 |
| 2021-01 | 0 | 2 |
| 2021-02 | 0 | 4 |
| 2021-03 | 0 | 2 |
| 2021-05 | 0 | 1 |
| 2021-11 | 0 | 1 |
| 2021-12 | 0 | 1 |
| 2022-03 | 0 | 1 |
| 2022-04 | 0 | 1.75 |
| 2022-07 | 0 | 1 |
| 2022-09 | 0 | 1 |
| 2023-01 | 2 | 1.2 |
| 2023-02 | 4 | 1.6 |
| 2023-03 | 0 | 1 |
| 2023-06 | 0 | 1 |
| 2023-08 | 0 | 1 |
| 2023-10 | 0 | 3 |
| 2023-12 | 0 | 1 |
| 2024-01 | 0 | 1 |
| 2024-02 | 0 | 1 |
| 2024-03 | 0 | 1 |
| 2024-07 | 0 | 1 |
| 2024-09 | 0 | 2 |
| 2024-10 | 0 | 1.38 |
| 2024-12 | 0 | 4 |
| 2025-02 | 0 | 1 |
| 2025-03 | 0 | 1.33 |
| 2025-04 | 0 | 2.13 |
| 2025-06 | 0 | 1 |
| 2025-08 | 0 | 1 |
| 2025-09 | 0 | 1 |
| 2025-12 | 0 | 1.2 |
| 2026-01 | 0 | 1 |
| 2026-02 | 0 | 1 |
| 2026-03 | 0 | 1.8 |
| 2026-04 | 0 | 1 |
Failure-mode summaryAI-generated
6 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2023-02-02 | 1220828-2023-00003 | Injury | Available | catalog number |
| 2023-02-02 | 9610691-2023-00004 | Malfunction | Available | catalog number |
| 2023-01-04 | 16093938 | Malfunction | Available | catalog number |
Showing the most recent 3 of 6 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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