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.
8 linked reportsInjury 4Malfunction 4
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.5 |
| 2019-02 | 0 | 4.67 |
| 2019-03 | 0 | 4.5 |
| 2019-04 | 0 | 7.08 |
| 2019-05 | 0 | 3.75 |
| 2019-06 | 0 | 2.8 |
| 2019-07 | 0 | 7.5 |
| 2019-08 | 0 | 2.5 |
| 2019-09 | 0 | 15.7 |
| 2019-10 | 0 | 9.18 |
| 2019-11 | 0 | 5.11 |
| 2019-12 | 2 | 8.57 |
| 2020-01 | 0 | 5.14 |
| 2020-02 | 0 | 5 |
| 2020-03 | 0 | 7.86 |
| 2020-04 | 0 | 5.8 |
| 2020-05 | 0 | 3 |
| 2020-06 | 0 | 2.57 |
| 2020-07 | 0 | 5.13 |
| 2020-08 | 0 | 6.71 |
| 2020-09 | 0 | 6.83 |
| 2020-10 | 0 | 5.78 |
| 2020-11 | 0 | 6.86 |
| 2020-12 | 0 | 6.88 |
| 2021-01 | 0 | 7.14 |
| 2021-02 | 0 | 5 |
| 2021-03 | 0 | 10.57 |
| 2021-04 | 0 | 8.71 |
| 2021-05 | 0 | 5.71 |
| 2021-06 | 0 | 6.11 |
| 2021-07 | 0 | 3.71 |
| 2021-08 | 0 | 7 |
| 2021-09 | 0 | 6 |
| 2021-10 | 0 | 6.83 |
| 2021-11 | 0 | 6.83 |
| 2021-12 | 0 | 6.3 |
| 2022-01 | 0 | 4.57 |
| 2022-02 | 0 | 4.86 |
| 2022-03 | 0 | 9.57 |
| 2022-04 | 0 | 8.11 |
| 2022-05 | 0 | 8.38 |
| 2022-06 | 0 | 23.4 |
| 2022-07 | 0 | 16.14 |
| 2022-08 | 2 | 13 |
| 2022-09 | 0 | 16.57 |
| 2022-10 | 0 | 12.63 |
| 2022-11 | 0 | 10.88 |
| 2022-12 | 0 | 9.27 |
| 2023-01 | 0 | 9 |
| 2023-02 | 0 | 12.5 |
| 2023-03 | 0 | 7.86 |
| 2023-04 | 0 | 7.9 |
| 2023-05 | 0 | 8.58 |
| 2023-06 | 0 | 11.89 |
| 2023-07 | 0 | 9.67 |
| 2023-08 | 0 | 10.55 |
| 2023-09 | 0 | 14.3 |
| 2023-10 | 0 | 21.35 |
| 2023-11 | 0 | 19.22 |
| 2023-12 | 0 | 22.15 |
| 2024-01 | 0 | 9.08 |
| 2024-02 | 0 | 10.15 |
| 2024-03 | 0 | 18.25 |
| 2024-04 | 0 | 20.53 |
| 2024-05 | 0 | 19.28 |
| 2024-06 | 0 | 20.83 |
| 2024-07 | 0 | 20.3 |
| 2024-08 | 0 | 22.25 |
| 2024-09 | 0 | 21.04 |
| 2024-10 | 0 | 25.22 |
| 2024-11 | 0 | 26.25 |
| 2024-12 | 0 | 21.05 |
| 2025-01 | 0 | 23.68 |
| 2025-02 | 0 | 19.05 |
| 2025-03 | 0 | 28.65 |
| 2025-04 | 0 | 48.27 |
| 2025-05 | 0 | 69.36 |
| 2025-06 | 0 | 56.35 |
| 2025-07 | 2 | 48.93 |
| 2025-08 | 2 | 35.75 |
| 2025-09 | 0 | 33.3 |
| 2025-10 | 0 | 34.56 |
| 2025-11 | 0 | 33.71 |
| 2025-12 | 0 | 48.9 |
| 2026-01 | 0 | 35.25 |
| 2026-02 | 0 | 54.15 |
| 2026-03 | 0 | 38.83 |
| 2026-04 | 0 | 49.1 |
| 2026-05 | 0 | 46.68 |
| 2026-06 | 0 | 38.65 |
Failure-mode summaryAI-generated
8 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2017-07-14 | Z-0846-2018 | Class II | Terminated | A software issue may result in the previous settings being applied instead of the default settings or the unit may skip the startup leak test.Distribution: Worldwide Distribution - US Nationwide | 2875 in total | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-08-15 | 2221819-2025-00018 | Injury | Available | procode brand trgm |
| 2025-08-15 | 3009156722-2025-00018 | Injury | Available | procode brand trgm |
| 2025-07-08 | 2221819-2025-00011 | Malfunction | Available | exact di |
| 2025-07-08 | 3009156722-2025-00011 | Malfunction | Available | exact di |
| 2022-08-24 | 3009156722-2022-00018 | Injury | Available | procode brand trgm |
| 2022-08-24 | 2221819-2022-00018 | Injury | Available | procode brand trgm |
| 2019-12-24 | 3009156722-2019-00008 | Malfunction | Available | procode brand trgm |
| 2019-12-24 | 2221819-2019-00008 | Malfunction | Available | procode brand trgm |
Regulatory clearances
- 510(k)K253330Substantially equivalent (SESE) · 2026-06-25clearance family
- 510(k)K171311Substantially equivalent (SESE) · 2018-01-12clearance family
- 510(k)K123211Substantially equivalent (SESE) · 2013-02-14clearance family
Predicate lineage
- K171311
- K083050
- K110213
- K123211
- K132530
- K151954
- K170876
Cited as predicate by: K253330
- K253330
- K121225
- K171311
- K083050
- K110213
- K123211
- K132530
- K151954
- K170876
- K192972
- K201874
- K201957
- K220107
- K230693
- K230931
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2017-04-14 | NAI | No action indicated | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 0 |
| 2017-04-14 | VAI | Voluntary action indicated | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | 0 |
| 2017-04-14 | VAI | Voluntary action indicated | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | 0 |
| 2017-04-14 | NAI | No action indicated | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 0 |
| 2015-05-15 | VAI | Voluntary action indicated | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 1 |
| 2012-04-12 | VAI | Voluntary action indicated | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 5 |
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