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.
1 linked reportInjury 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 4.1 |
| 2019-02 | 0 | 1.83 |
| 2019-03 | 0 | 6.43 |
| 2019-04 | 0 | 3.91 |
| 2019-05 | 0 | 4 |
| 2019-06 | 0 | 4.4 |
| 2019-07 | 0 | 3.44 |
| 2019-08 | 0 | 3 |
| 2019-09 | 0 | 3.75 |
| 2019-10 | 0 | 3.47 |
| 2019-11 | 0 | 2.47 |
| 2019-12 | 0 | 2.93 |
| 2020-01 | 0 | 6 |
| 2020-02 | 0 | 3.79 |
| 2020-03 | 0 | 6 |
| 2020-04 | 0 | 4 |
| 2020-05 | 0 | 2.89 |
| 2020-06 | 0 | 3.23 |
| 2020-07 | 0 | 3.83 |
| 2020-08 | 0 | 3.73 |
| 2020-09 | 0 | 4.73 |
| 2020-10 | 0 | 3.5 |
| 2020-11 | 0 | 4.92 |
| 2020-12 | 0 | 5.45 |
| 2021-01 | 0 | 4.17 |
| 2021-02 | 0 | 4.08 |
| 2021-03 | 0 | 4.55 |
| 2021-04 | 0 | 5.07 |
| 2021-05 | 0 | 9.08 |
| 2021-06 | 0 | 5.42 |
| 2021-07 | 0 | 4.06 |
| 2021-08 | 0 | 6.82 |
| 2021-09 | 0 | 4.25 |
| 2021-10 | 0 | 2.63 |
| 2021-11 | 0 | 3.33 |
| 2021-12 | 0 | 4.5 |
| 2022-01 | 0 | 4.6 |
| 2022-02 | 0 | 4.82 |
| 2022-03 | 0 | 4.67 |
| 2022-04 | 0 | 3.82 |
| 2022-05 | 0 | 3.1 |
| 2022-06 | 0 | 2.82 |
| 2022-07 | 0 | 2.71 |
| 2022-08 | 0 | 2.19 |
| 2022-09 | 0 | 3.53 |
| 2022-10 | 0 | 3.25 |
| 2022-11 | 0 | 2.4 |
| 2022-12 | 0 | 3.54 |
| 2023-01 | 0 | 3.3 |
| 2023-02 | 0 | 3.76 |
| 2023-03 | 0 | 3.38 |
| 2023-04 | 0 | 2.69 |
| 2023-05 | 0 | 3.22 |
| 2023-06 | 0 | 3.71 |
| 2023-07 | 0 | 2.31 |
| 2023-08 | 0 | 2.6 |
| 2023-09 | 0 | 2.62 |
| 2023-10 | 0 | 2.27 |
| 2023-11 | 0 | 4.73 |
| 2023-12 | 1 | 10.35 |
| 2024-01 | 0 | 5.57 |
| 2024-02 | 0 | 7.93 |
| 2024-03 | 0 | 6.3 |
| 2024-04 | 0 | 8.28 |
| 2024-05 | 0 | 8.27 |
| 2024-06 | 0 | 10.71 |
| 2024-07 | 0 | 3.19 |
| 2024-08 | 0 | 5.05 |
| 2024-09 | 0 | 5.5 |
| 2024-10 | 0 | 4.42 |
| 2024-11 | 0 | 4.62 |
| 2024-12 | 0 | 3.08 |
| 2025-01 | 0 | 4.91 |
| 2025-02 | 0 | 4.2 |
| 2025-03 | 0 | 3.96 |
| 2025-04 | 0 | 5.17 |
| 2025-05 | 0 | 6.25 |
| 2025-06 | 0 | 2.69 |
| 2025-07 | 0 | 5.17 |
| 2025-08 | 0 | 4.76 |
| 2025-09 | 0 | 4.24 |
| 2025-10 | 0 | 3.5 |
| 2025-11 | 0 | 4.55 |
| 2025-12 | 0 | 5.19 |
| 2026-01 | 0 | 5.31 |
| 2026-02 | 0 | 6.25 |
| 2026-03 | 0 | 3.76 |
| 2026-04 | 0 | 5.63 |
| 2026-05 | 0 | 3.86 |
| 2026-06 | 0 | 2.35 |
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2023-12-14 | 3010342616-2023-00001 | Injury | Available | exact di |
Regulatory clearances
- 510(k)K162503Substantially equivalent (SESE) · 2017-03-24clearance family
Predicate lineage
K162503
Cited as predicate by: K231620
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 |
|---|---|---|---|---|
| 2025-02-07 | VAI | Voluntary action indicated | Cardiac Insight, Inc. | 2 |
| 2025-02-07 | VAI | Voluntary action indicated | Cardiac Insight, Inc. | 2 |
| 2017-02-10 | VAI | Voluntary action indicated | Cardiac Insight, Inc. | 2 |
| 2017-02-10 | VAI | Voluntary action indicated | Cardiac Insight, Inc. | 2 |
| 2014-05-09 | NAI | No action indicated | Cardiac Insight, Inc. | 0 |
| 2014-05-09 | NAI | No action indicated | Cardiac Insight, Inc. | 0 |
Similar devices
- Cardio Server EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
- 12 Pneumatic Endo probes for Endo PAT 2000 ITAMAR MEDICAL LTD
- 12-Ch ECG Holter Patient Cable w/10 Leads VASOMEDICAL, INC.
- 2GB SD Memory Card VASOMEDICAL, INC.
- 3-Ch ECG Holter Patient Cable w/5 Leads VASOMEDICAL, INC.
- 3-Ch ECG Holter Patient Cable w/7 Leads VASOMEDICAL, INC.
- ABPM pro basic device SOMNOmedics AG
- ABPMpro cuff for right arm SOMNOmedics AG
- ACUMEN IQ Edwards Lifesciences LLC
- ACUMEN IQ Edwards Lifesciences LLC
- AT-Patch ATsens Co., Ltd.
- AT-Patch ATsens Co., Ltd.
Select up to two to place side-by-side with this device.