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.
3 linked reportsMalfunction 3
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 12.93 |
| 2019-02 | 0 | 11.79 |
| 2019-03 | 0 | 12.97 |
| 2019-04 | 0 | 11.71 |
| 2019-05 | 0 | 10.48 |
| 2019-06 | 0 | 9.72 |
| 2019-07 | 0 | 10.9 |
| 2019-08 | 0 | 9.83 |
| 2019-09 | 0 | 16.02 |
| 2019-10 | 0 | 11.11 |
| 2019-11 | 0 | 12.37 |
| 2019-12 | 0 | 12.75 |
| 2020-01 | 0 | 12.4 |
| 2020-02 | 0 | 11.03 |
| 2020-03 | 0 | 12.85 |
| 2020-04 | 0 | 12.04 |
| 2020-05 | 0 | 9.29 |
| 2020-06 | 0 | 9.65 |
| 2020-07 | 0 | 7.84 |
| 2020-08 | 0 | 11.4 |
| 2020-09 | 0 | 10.67 |
| 2020-10 | 0 | 10.2 |
| 2020-11 | 0 | 13.69 |
| 2020-12 | 0 | 10.47 |
| 2021-01 | 0 | 9.62 |
| 2021-02 | 0 | 9.37 |
| 2021-03 | 0 | 12.63 |
| 2021-04 | 0 | 10.32 |
| 2021-05 | 0 | 8.6 |
| 2021-06 | 0 | 9.69 |
| 2021-07 | 0 | 7.61 |
| 2021-08 | 0 | 8.14 |
| 2021-09 | 0 | 8.93 |
| 2021-10 | 0 | 7.56 |
| 2021-11 | 0 | 8.99 |
| 2021-12 | 0 | 7.94 |
| 2022-01 | 0 | 7.93 |
| 2022-02 | 0 | 7.78 |
| 2022-03 | 0 | 9.76 |
| 2022-04 | 0 | 9.64 |
| 2022-05 | 0 | 11.9 |
| 2022-06 | 0 | 8.32 |
| 2022-07 | 0 | 6.23 |
| 2022-08 | 0 | 8.56 |
| 2022-09 | 0 | 9.6 |
| 2022-10 | 0 | 13.89 |
| 2022-11 | 0 | 8.55 |
| 2022-12 | 0 | 10.23 |
| 2023-01 | 0 | 8.31 |
| 2023-02 | 0 | 15.03 |
| 2023-03 | 0 | 16.22 |
| 2023-04 | 0 | 15.24 |
| 2023-05 | 0 | 15.91 |
| 2023-06 | 0 | 12.14 |
| 2023-07 | 0 | 22.06 |
| 2023-08 | 0 | 22.12 |
| 2023-09 | 0 | 22 |
| 2023-10 | 0 | 13.77 |
| 2023-11 | 0 | 23.4 |
| 2023-12 | 0 | 19.19 |
| 2024-01 | 0 | 21.92 |
| 2024-02 | 0 | 16.96 |
| 2024-03 | 0 | 19.29 |
| 2024-04 | 0 | 12.9 |
| 2024-05 | 0 | 15.4 |
| 2024-06 | 0 | 12 |
| 2024-07 | 0 | 17.29 |
| 2024-08 | 0 | 15.32 |
| 2024-09 | 0 | 19.53 |
| 2024-10 | 0 | 25.42 |
| 2024-11 | 0 | 17.91 |
| 2024-12 | 2 | 15.72 |
| 2025-01 | 0 | 19.13 |
| 2025-02 | 0 | 14.75 |
| 2025-03 | 0 | 17.63 |
| 2025-04 | 0 | 11.42 |
| 2025-05 | 0 | 11.73 |
| 2025-06 | 0 | 8.71 |
| 2025-07 | 0 | 9.64 |
| 2025-08 | 0 | 8.82 |
| 2025-09 | 0 | 6.98 |
| 2025-10 | 0 | 10.96 |
| 2025-11 | 0 | 8.16 |
| 2025-12 | 0 | 8.42 |
| 2026-01 | 0 | 8.67 |
| 2026-02 | 1 | 8.1 |
| 2026-03 | 0 | 9.38 |
| 2026-04 | 0 | 20.39 |
| 2026-05 | 0 | 11.86 |
| 2026-06 | 0 | 10.35 |
Failure-mode summaryAI-generated
3 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2026-02-27 | Z-1793-2026 | Class II | Open, Classified | Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurement or Irregular Curve error with CO measurement not automatically excluded, which may result in inaccurate readings, or the need of additional readings, which may lead to delayed care and/or fluid overload.Distribution: Worldwide - US Nationwide distribution including in the states of NY, NJ, AL, OK, IA, MT, WY, MN, TX, WI, PA, WA, OR, MI, CA, SC, ID, FL, MS, KS, SD, LA, OH, MO, NH, GA, MD, TN, AZ, PR and the countries of TAIWAN, CANADA, KUWAIT, FRANCE, SAUDI ARABIA, POLAND, PAKISTAN, MEXICO, ARGENTINA, PANAMA. | 1790 | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-02-19 | 3010157426-2026-00042 | Malfunction | Available | exact di |
| 2024-12-06 | 3010157426-2024-00185 | Malfunction | Available | exact di |
| 2024-12-05 | 3010157426-2024-00186 | Malfunction | Available | exact di |
Regulatory clearances
Manufacturer compliance record
None in the loaded window.
Similar devices
- 7 Series Blood Pressure Monitor Omron Healthcare, Inc.
- BBLOVE Arm Blood Pressure Monitor Alicn Medical Shenzhen, Inc.
- BabySat 3 Rx Base Station Owlet Baby Care, Inc.
- Bytech Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.
- CO-Pilot™ Wireless Handheld Multi-Parameter System NONIN MEDICAL, INC.
- CO-Pilot™ Wireless Handheld Multi-Parameter System NONIN MEDICAL, INC.
- CO-Pilot™ Wireless Handheld Multi-Parameter System NONIN MEDICAL, INC.
- CO-Pilot™ Wireless Handheld Multi-Parameter System NONIN MEDICAL, INC.
- KITMAN Shenzhen Jamr Technology Co., Ltd.
- NO Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.
- PEAKME Shenzhen Changkun Technology Co., Ltd.
- PREVE Guangzhou Berrcom Medical Device Co., Ltd
Select up to two to place side-by-side with this device.