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.
2 linked reports Malfunction 2
9 18 27 36 2019-02: 0 reports for this device; peer average 2/device 2019-03: 0 reports for this device; peer average 1/device 2019-05: 0 reports for this device; peer average 2/device 2019-08: 0 reports for this device; peer average 3/device 2019-09: 0 reports for this device; peer average 4/device 2019-10: 0 reports for this device; peer average 2/device 2019-12: 0 reports for this device; peer average 1/device 2020-02: 0 reports for this device; peer average 1/device 2020-04: 0 reports for this device; peer average 2.5/device 2020-06: 0 reports for this device; peer average 1.33/device 2020-07: 0 reports for this device; peer average 2.5/device 2020-08: 0 reports for this device; peer average 1.33/device 2020-09: 0 reports for this device; peer average 2.25/device 2020-10: 0 reports for this device; peer average 2/device 2020-11: 0 reports for this device; peer average 2/device 2020-12: 0 reports for this device; peer average 5.67/device 2021-01: 0 reports for this device; peer average 3.75/device 2021-02: 0 reports for this device; peer average 10.43/device 2021-03: 0 reports for this device; peer average 4/device 2021-04: 0 reports for this device; peer average 2.33/device 2021-05: 0 reports for this device; peer average 2.6/device 2021-06: 0 reports for this device; peer average 3.8/device 2021-07: 0 reports for this device; peer average 3.44/device 2021-08: 0 reports for this device; peer average 3/device 2021-09: 0 reports for this device; peer average 3.5/device 2021-10: 0 reports for this device; peer average 3.5/device 2021-11: 0 reports for this device; peer average 4/device 2021-12: 0 reports for this device; peer average 4.5/device 2022-01: 0 reports for this device; peer average 3.33/device 2022-02: 0 reports for this device; peer average 3/device 2022-03: 0 reports for this device; peer average 4/device 2022-04: 0 reports for this device; peer average 3.33/device 2022-05: 0 reports for this device; peer average 3/device 2022-06: 0 reports for this device; peer average 3/device 2022-07: 0 reports for this device; peer average 3.44/device 2022-08: 0 reports for this device; peer average 2.5/device 2022-09: 0 reports for this device; peer average 3.4/device 2022-10: 0 reports for this device; peer average 4/device 2022-11: 0 reports for this device; peer average 3.36/device 2022-12: 0 reports for this device; peer average 2.9/device 2023-01: 0 reports for this device; peer average 2.7/device 2023-02: 0 reports for this device; peer average 2.77/device 2023-03: 0 reports for this device; peer average 2.44/device 2023-04: 0 reports for this device; peer average 4/device 2023-05: 0 reports for this device; peer average 2.55/device 2023-06: 0 reports for this device; peer average 3.42/device 2023-07: 0 reports for this device; peer average 3.08/device 2023-08: 0 reports for this device; peer average 2.67/device 2023-09: 0 reports for this device; peer average 2.38/device 2023-10: 0 reports for this device; peer average 3.75/device 2023-11: 0 reports for this device; peer average 3.5/device 2023-12: 0 reports for this device; peer average 7.82/device 2024-01: 0 reports for this device; peer average 5.67/device 2024-02: 0 reports for this device; peer average 7.1/device 2024-03: 0 reports for this device; peer average 7.2/device 2024-04: 0 reports for this device; peer average 3.4/device 2024-05: 0 reports for this device; peer average 2.17/device 2024-06: 0 reports for this device; peer average 3.42/device 2024-07: 0 reports for this device; peer average 3.42/device 2024-08: 0 reports for this device; peer average 4.42/device 2024-09: 0 reports for this device; peer average 2.4/device 2024-10: 0 reports for this device; peer average 3.67/device 2024-11: 0 reports for this device; peer average 2.18/device 2024-12: 0 reports for this device; peer average 1/device 2025-01: 0 reports for this device; peer average 1.82/device 2025-02: 0 reports for this device; peer average 3.09/device 2025-03: 0 reports for this device; peer average 2.38/device 2025-04: 0 reports for this device; peer average 2.43/device 2025-05: 0 reports for this device; peer average 3.36/device 2025-06: 0 reports for this device; peer average 2.91/device 2025-07: 0 reports for this device; peer average 4/device 2025-08: 0 reports for this device; peer average 5.85/device 2025-09: 0 reports for this device; peer average 6.22/device 2025-10: 0 reports for this device; peer average 36.23/device 2025-11: 0 reports for this device; peer average 13.06/device 2025-12: 0 reports for this device; peer average 4.82/device 2026-01: 0 reports for this device; peer average 10.87/device 2026-02: 0 reports for this device; peer average 8.38/device 2026-03: 0 reports for this device; peer average 5.27/device 2026-04: 0 reports for this device; peer average 16.2/device 2026-05: 2 reports for this device; peer average 11.9/device 2026-06: 0 reports for this device; peer average 12.06/device 02 03 05 08 09 10 12 02 04 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 Monthly adverse-event reports for this device versus the product-code average. Month This device (reports) Product-code average (reports per device) 2019-02 0 2 2019-03 0 1 2019-05 0 2 2019-08 0 3 2019-09 0 4 2019-10 0 2 2019-12 0 1 2020-02 0 1 2020-04 0 2.5 2020-06 0 1.33 2020-07 0 2.5 2020-08 0 1.33 2020-09 0 2.25 2020-10 0 2 2020-11 0 2 2020-12 0 5.67 2021-01 0 3.75 2021-02 0 10.43 2021-03 0 4 2021-04 0 2.33 2021-05 0 2.6 2021-06 0 3.8 2021-07 0 3.44 2021-08 0 3 2021-09 0 3.5 2021-10 0 3.5 2021-11 0 4 2021-12 0 4.5 2022-01 0 3.33 2022-02 0 3 2022-03 0 4 2022-04 0 3.33 2022-05 0 3 2022-06 0 3 2022-07 0 3.44 2022-08 0 2.5 2022-09 0 3.4 2022-10 0 4 2022-11 0 3.36 2022-12 0 2.9 2023-01 0 2.7 2023-02 0 2.77 2023-03 0 2.44 2023-04 0 4 2023-05 0 2.55 2023-06 0 3.42 2023-07 0 3.08 2023-08 0 2.67 2023-09 0 2.38 2023-10 0 3.75 2023-11 0 3.5 2023-12 0 7.82 2024-01 0 5.67 2024-02 0 7.1 2024-03 0 7.2 2024-04 0 3.4 2024-05 0 2.17 2024-06 0 3.42 2024-07 0 3.42 2024-08 0 4.42 2024-09 0 2.4 2024-10 0 3.67 2024-11 0 2.18 2024-12 0 1 2025-01 0 1.82 2025-02 0 3.09 2025-03 0 2.38 2025-04 0 2.43 2025-05 0 3.36 2025-06 0 2.91 2025-07 0 4 2025-08 0 5.85 2025-09 0 6.22 2025-10 0 36.23 2025-11 0 13.06 2025-12 0 4.82 2026-01 0 10.87 2026-02 0 8.38 2026-03 0 5.27 2026-04 0 16.2 2026-05 2 11.9 2026-06 0 12.06
Failure-mode summaryAI-generated
2 linked report narratives available — no AI summary generated yet.
Manufacturer compliance record
Date Type Outcome Facility Citations 2014-08-21 NAI No action indicated Medimaging Integrated Solution, Inc. 0
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