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.
95 linked reportsMalfunction 82Death 8Injury 5
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 12.75 |
| 2019-02 | 0 | 10.69 |
| 2019-03 | 0 | 12.4 |
| 2019-04 | 0 | 10.97 |
| 2019-05 | 0 | 9.77 |
| 2019-06 | 0 | 8.48 |
| 2019-07 | 0 | 9.7 |
| 2019-08 | 0 | 8.85 |
| 2019-09 | 0 | 14.22 |
| 2019-10 | 0 | 10.39 |
| 2019-11 | 0 | 11.83 |
| 2019-12 | 0 | 11.03 |
| 2020-01 | 0 | 11.25 |
| 2020-02 | 0 | 9.88 |
| 2020-03 | 0 | 11.87 |
| 2020-04 | 0 | 11.36 |
| 2020-05 | 0 | 8.64 |
| 2020-06 | 0 | 8.8 |
| 2020-07 | 0 | 7.56 |
| 2020-08 | 0 | 10.31 |
| 2020-09 | 0 | 9.19 |
| 2020-10 | 0 | 9.68 |
| 2020-11 | 0 | 12.69 |
| 2020-12 | 0 | 9.91 |
| 2021-01 | 0 | 8.89 |
| 2021-02 | 0 | 8.61 |
| 2021-03 | 0 | 11.75 |
| 2021-04 | 0 | 9.32 |
| 2021-05 | 0 | 8.38 |
| 2021-06 | 0 | 8.91 |
| 2021-07 | 0 | 7.14 |
| 2021-08 | 0 | 7.69 |
| 2021-09 | 0 | 7.75 |
| 2021-10 | 0 | 6.22 |
| 2021-11 | 0 | 8.22 |
| 2021-12 | 0 | 7.68 |
| 2022-01 | 0 | 7.3 |
| 2022-02 | 0 | 6.92 |
| 2022-03 | 0 | 8.92 |
| 2022-04 | 0 | 8.39 |
| 2022-05 | 0 | 10.23 |
| 2022-06 | 0 | 7.34 |
| 2022-07 | 0 | 5.68 |
| 2022-08 | 0 | 8.11 |
| 2022-09 | 0 | 8.28 |
| 2022-10 | 0 | 12.27 |
| 2022-11 | 0 | 7.66 |
| 2022-12 | 0 | 8.08 |
| 2023-01 | 0 | 7.26 |
| 2023-02 | 0 | 14.28 |
| 2023-03 | 0 | 13.54 |
| 2023-04 | 0 | 12.32 |
| 2023-05 | 0 | 13.67 |
| 2023-06 | 0 | 10.62 |
| 2023-07 | 0 | 18.48 |
| 2023-08 | 0 | 17.14 |
| 2023-09 | 0 | 18.18 |
| 2023-10 | 0 | 11.78 |
| 2023-11 | 0 | 18.96 |
| 2023-12 | 0 | 15.86 |
| 2024-01 | 0 | 18.7 |
| 2024-02 | 0 | 14.5 |
| 2024-03 | 0 | 15.33 |
| 2024-04 | 0 | 10.91 |
| 2024-05 | 25 | 13.89 |
| 2024-06 | 10 | 10.24 |
| 2024-07 | 12 | 14.51 |
| 2024-08 | 11 | 12.46 |
| 2024-09 | 1 | 13.77 |
| 2024-10 | 1 | 18.19 |
| 2024-11 | 0 | 15.03 |
| 2024-12 | 16 | 12.67 |
| 2025-01 | 0 | 16.93 |
| 2025-02 | 10 | 12.12 |
| 2025-03 | 0 | 14.7 |
| 2025-04 | 1 | 8.63 |
| 2025-05 | 4 | 9.66 |
| 2025-06 | 0 | 7.57 |
| 2025-07 | 0 | 8.74 |
| 2025-08 | 0 | 7.85 |
| 2025-09 | 3 | 6.2 |
| 2025-10 | 1 | 9.07 |
| 2025-11 | 0 | 7.41 |
| 2025-12 | 0 | 7.62 |
| 2026-01 | 0 | 7.13 |
| 2026-02 | 0 | 7.51 |
| 2026-03 | 0 | 7.71 |
| 2026-04 | 0 | 17.15 |
| 2026-05 | 0 | 9.56 |
| 2026-06 | 0 | 8.4 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2024-05-22 | Z-2239-2024 | Class II | Open, Classified | Potential for inaccurate fetal heart rate measurements when monitoring multiples.Distribution: Worldwide distribution - US Nationwide and the countries of AD, AE, AR, AT, AU, BA, BE, BG, BH, BO, BR, CH, CL, CO, CY, CZ, DE, DZ, EG, ES, FI, FR, GB, GI, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JP, KE, KW, LB, LK, LS, LT, LU, LV, LY, MA, ME, MT, MU, MY, NA, NI, NL, NZ, OM, PA, PH, PK, PL, PR, PS, PT, QA, RE, RO, RU, SA, SE, SG, SI, SK, TH, TN, TR, TT, TW, VN, ZA. | 6,915 units | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-10-30 | 9610816-2025-001010 | Malfunction | Available | exact di |
| 2025-09-12 | 9610816-2025-000836 | Malfunction | Available | catalog number |
| 2025-09-09 | 9610816-2025-000823 | Malfunction | Available | catalog number |
| 2025-05-29 | 9610816-2025-000443 | Death | Available | catalog number |
| 2025-05-16 | 9610816-2025-000411 | Injury | Available | catalog number |
| 2025-04-15 | 9610816-2025-000307 | Malfunction | Available | catalog number |
| 2025-02-26 | 9610816-2025-000123 | Malfunction | Available | catalog number |
| 2025-02-18 | 9610816-2025-000107 | Malfunction | Available | catalog number |
| 2025-02-18 | 9610816-2025-000108 | Malfunction | Available | catalog number |
| 2025-02-18 | 9610816-2025-000110 | Malfunction | Available | catalog number |
| 2025-02-18 | 9610816-2025-000111 | Malfunction | Available | catalog number |
| 2024-12-27 | 9610816-2024-001018 | Malfunction | Available | catalog number |
| 2024-12-27 | 9610816-2024-001022 | Malfunction | Available | catalog number |
| 2024-12-27 | 9610816-2024-001021 | Malfunction | Available | catalog number |
| 2024-12-27 | 9610816-2024-001023 | Malfunction | Available | catalog number |
Showing the most recent 55 of 95 linked reports.
Showing 1–15 of 55
Regulatory clearances
None linked.
Manufacturer compliance record
None in the loaded window.
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