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.
43 linked reportsMalfunction 41No answer provided 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-06 | 0 | 3 |
| 2019-08 | 0 | 3 |
| 2020-01 | 0 | 6 |
| 2020-02 | 0 | 3 |
| 2020-03 | 0 | 3 |
| 2020-07 | 0 | 4 |
| 2020-08 | 0 | 4.5 |
| 2020-09 | 0 | 3 |
| 2020-10 | 0 | 3.5 |
| 2020-11 | 0 | 2 |
| 2020-12 | 0 | 3 |
| 2021-01 | 0 | 1 |
| 2021-02 | 0 | 2 |
| 2021-03 | 0 | 2.5 |
| 2021-04 | 0 | 1 |
| 2021-06 | 0 | 1 |
| 2021-07 | 0 | 2 |
| 2021-08 | 0 | 1 |
| 2021-09 | 0 | 2 |
| 2021-10 | 0 | 2 |
| 2021-11 | 0 | 1 |
| 2021-12 | 0 | 3.5 |
| 2022-01 | 0 | 3.5 |
| 2022-03 | 0 | 2.5 |
| 2022-05 | 0 | 2.33 |
| 2022-06 | 0 | 2 |
| 2022-07 | 0 | 1 |
| 2022-08 | 0 | 2 |
| 2022-09 | 0 | 4 |
| 2022-10 | 0 | 7 |
| 2022-11 | 0 | 2.5 |
| 2022-12 | 3 | 4 |
| 2023-01 | 4 | 4.25 |
| 2023-02 | 8 | 5.67 |
| 2023-03 | 0 | 6 |
| 2023-04 | 0 | 7 |
| 2023-05 | 0 | 3 |
| 2023-06 | 0 | 3 |
| 2023-07 | 6 | 5 |
| 2023-08 | 0 | 10 |
| 2023-09 | 1 | 4.5 |
| 2023-10 | 6 | 2.75 |
| 2023-11 | 0 | 5.5 |
| 2023-12 | 0 | 5 |
| 2024-01 | 0 | 2.33 |
| 2024-02 | 0 | 5 |
| 2024-03 | 0 | 2.67 |
| 2024-04 | 7 | 2.75 |
| 2024-05 | 0 | 1.5 |
| 2024-06 | 6 | 3 |
| 2024-07 | 0 | 1 |
| 2024-08 | 0 | 3.5 |
| 2024-09 | 0 | 1.75 |
| 2024-10 | 0 | 2.25 |
| 2024-11 | 2 | 7 |
| 2024-12 | 0 | 8 |
| 2025-01 | 0 | 1 |
| 2025-02 | 0 | 6 |
| 2025-03 | 0 | 1 |
| 2025-04 | 0 | 4.5 |
| 2025-05 | 0 | 4 |
| 2025-06 | 0 | 5.5 |
| 2025-07 | 0 | 12 |
| 2025-08 | 0 | 2 |
| 2025-09 | 0 | 5 |
| 2025-10 | 0 | 4.5 |
| 2025-11 | 0 | 3 |
| 2025-12 | 0 | 4 |
| 2026-01 | 0 | 8 |
| 2026-02 | 0 | 2 |
| 2026-03 | 0 | 6 |
| 2026-04 | 0 | 4.5 |
| 2026-06 | 0 | 4 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2024-11-13 | 1220828-2024-00020 | Malfunction | Available | procode brand trgm |
| 2024-11-13 | 9610691-2024-00019 | Malfunction | Available | procode brand trgm |
| 2024-06-12 | 1220828-2024-00012 | Malfunction | Available | catalog number |
| 2024-06-12 | 9610691-2024-00010 | Malfunction | Available | catalog number |
| 2024-04-04 | 9610691-2024-00005 | Malfunction | Available | catalog number |
| 2024-04-04 | 1220828-2024-00006 | Malfunction | Available | catalog number |
| 2023-10-19 | 9610691-2023-00024 | Malfunction | Available | catalog number |
| 2023-10-19 | 1220828-2023-00019 | Malfunction | Available | catalog number |
| 2023-09-21 | 17787686 | Malfunction | Available | procode brand trgm |
| 2023-07-05 | 1220828-2023-00013 | Malfunction | Available | catalog number |
| 2023-07-03 | 9610691-2023-00016 | Malfunction | Available | catalog number |
| 2023-02-22 | 1220828-2023-00007 | Malfunction | Available | catalog number |
| 2023-02-20 | 9610691-2023-00009 | Malfunction | Available | catalog number |
| 2023-02-16 | 9610691-2023-00006 | Malfunction | Available | catalog number |
| 2023-02-16 | 1220828-2023-00004 | No answer provided | Available | catalog number |
Showing the most recent 18 of 43 linked reports.
Showing 1–15 of 18
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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