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 reportsMalfunction 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 3.25 |
| 2019-02 | 0 | 4 |
| 2019-03 | 0 | 1.5 |
| 2019-04 | 0 | 3 |
| 2019-05 | 0 | 2.4 |
| 2019-06 | 0 | 2 |
| 2019-07 | 0 | 3.33 |
| 2019-08 | 0 | 3.83 |
| 2019-09 | 0 | 2.5 |
| 2019-10 | 0 | 3.17 |
| 2019-11 | 0 | 3 |
| 2019-12 | 0 | 3.4 |
| 2020-01 | 0 | 2.78 |
| 2020-02 | 0 | 2.17 |
| 2020-03 | 0 | 3.67 |
| 2020-04 | 0 | 3.33 |
| 2020-05 | 0 | 3 |
| 2020-06 | 0 | 4.78 |
| 2020-07 | 0 | 35 |
| 2020-08 | 0 | 20 |
| 2020-09 | 0 | 21 |
| 2020-10 | 0 | 13.6 |
| 2020-11 | 0 | 47.5 |
| 2020-12 | 0 | 9.88 |
| 2021-01 | 0 | 9.14 |
| 2021-02 | 0 | 14.33 |
| 2021-03 | 0 | 14.25 |
| 2021-04 | 0 | 11.09 |
| 2021-05 | 0 | 12 |
| 2021-06 | 0 | 6 |
| 2021-07 | 0 | 1.63 |
| 2021-08 | 0 | 1 |
| 2021-09 | 0 | 1 |
| 2021-10 | 0 | 1.25 |
| 2021-11 | 0 | 1.64 |
| 2021-12 | 0 | 1.33 |
| 2022-01 | 0 | 1.6 |
| 2022-02 | 0 | 6.6 |
| 2022-03 | 0 | 1.86 |
| 2022-04 | 0 | 1.67 |
| 2022-05 | 0 | 1.4 |
| 2022-06 | 0 | 2.14 |
| 2022-07 | 0 | 1.29 |
| 2022-08 | 0 | 1.09 |
| 2022-09 | 0 | 2.17 |
| 2022-10 | 0 | 1.64 |
| 2022-11 | 0 | 1.5 |
| 2022-12 | 0 | 1.54 |
| 2023-01 | 0 | 2 |
| 2023-02 | 0 | 2 |
| 2023-03 | 0 | 2 |
| 2023-04 | 0 | 1.26 |
| 2023-05 | 0 | 2.14 |
| 2023-06 | 0 | 2.75 |
| 2023-07 | 0 | 1.5 |
| 2023-08 | 0 | 1.57 |
| 2023-09 | 0 | 1.36 |
| 2023-10 | 0 | 1.83 |
| 2023-11 | 0 | 1.44 |
| 2023-12 | 0 | 1.7 |
| 2024-01 | 0 | 1.92 |
| 2024-02 | 0 | 2.89 |
| 2024-03 | 0 | 1.73 |
| 2024-04 | 0 | 2.33 |
| 2024-05 | 0 | 2.22 |
| 2024-06 | 0 | 2.57 |
| 2024-07 | 0 | 2.31 |
| 2024-08 | 0 | 4.25 |
| 2024-09 | 0 | 2.13 |
| 2024-10 | 0 | 3.42 |
| 2024-11 | 0 | 3.71 |
| 2024-12 | 0 | 2.57 |
| 2025-01 | 0 | 2 |
| 2025-02 | 0 | 3.58 |
| 2025-03 | 0 | 5.86 |
| 2025-04 | 0 | 1.75 |
| 2025-05 | 0 | 1.8 |
| 2025-06 | 0 | 2.13 |
| 2025-07 | 0 | 1.61 |
| 2025-08 | 0 | 1.75 |
| 2025-09 | 0 | 1 |
| 2025-10 | 0 | 2 |
| 2025-11 | 0 | 2 |
| 2025-12 | 0 | 1.1 |
| 2026-01 | 0 | 2.2 |
| 2026-02 | 0 | 1.5 |
| 2026-03 | 1 | 2.43 |
| 2026-04 | 0 | 1.79 |
| 2026-05 | 0 | 2.17 |
| 2026-06 | 1 | 1.5 |
Failure-mode summaryAI-generated
2 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2026-04-21 | Z-2638-2026 | Class II | Open, Classified | The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the Upper Back Section H V U component on Baxter operating tables.Distribution: Worldwide - US Nationwide distribution in the states of Minnesota, Maryland, and Pennsylvania and the countries of Canada, Hong Kong, India, Japan, Korea, Philippines, Taiwan, Thailand, Vietnam, Austria, Belgium, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iraq, Israel, Italy, Jordan, Kenya, Lebanon, Libya, Malta, Morocco, Netherlands, Norway, Oman, Pakistan, Poland, Portugal, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Slovakia, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arabia Emrites, Ukraine, Argentina, Brazil, Chile, Colombia, Costa Rica, Mexico, and Peru. | 13 units | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-01 | 3007143268-2026-00032 | Malfunction | Available | exact di |
| 2026-03-03 | 3007143268-2026-00011 | Malfunction | Available | exact di |
Regulatory clearances
None linked.
Manufacturer compliance record
None in the loaded window.
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