Regulatory presence across jurisdictions
The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.
- United StatesNIMBUS05055982782234
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.
15 linked reportsMalfunction 13Death 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2022-09 | 2 | — |
| 2022-11 | 1 | — |
| 2023-05 | 1 | — |
| 2023-06 | 1 | — |
| 2024-10 | 1 | — |
| 2025-04 | 1 | — |
| 2025-05 | 3 | — |
| 2025-08 | 2 | — |
| 2025-09 | 1 | — |
| 2025-10 | 1 | — |
| 2025-11 | 1 | — |
Failure-mode summaryAI-generated
15 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-11-19 | 3005619970-2025-00061 | Malfunction | Available | exact di |
| 2025-10-20 | 3005619970-2025-00055 | Malfunction | Available | exact di |
| 2025-09-12 | 3005619970-2025-00044 | Malfunction | Available | exact di |
| 2025-08-19 | 3005619970-2025-00039 | Malfunction | Available | exact di |
| 2025-08-14 | 3005619970-2025-00042 | Malfunction | Available | exact di |
| 2025-05-15 | 3005619970-2025-00017 | Malfunction | Available | exact di |
| 2025-05-15 | 3005619970-2025-00018 | Malfunction | Available | exact di |
| 2025-05-15 | 3005619970-2025-00019 | Malfunction | Available | exact di |
| 2025-04-03 | 3005619970-2025-00012 | Malfunction | Available | exact di |
| 2024-10-30 | 3005619970-2024-00033 | Malfunction | Available | exact di |
| 2023-06-21 | 3005619970-2023-00015 | Malfunction | Available | exact di |
| 2023-05-16 | 3005619970-2023-00009 | Malfunction | Available | exact di |
| 2022-11-02 | 3005619970-2022-00025 | Malfunction | Available | exact di |
| 2022-09-09 | 1419652-2022-00040 | Death | Available | exact di |
| 2022-09-09 | 3005619970-2022-00018 | Death | Available | exact di |
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2015-04-23 | NAI | No action indicated | Arjo (Suzhou) Co., Ltd. | 0 |
| 2014-03-20 | VAI | Voluntary action indicated | ARJOHUNTLEIGH POLSKA Sp. z.o.o. | 3 |
| 2013-02-07 | NAI | No action indicated | ARJOHUNTLEIGH AB | 0 |
| 2013-02-07 | NAI | No action indicated | ARJOHUNTLEIGH AB | 0 |
| 2012-09-06 | VAI | Voluntary action indicated | Huntleigh Healthcare Ltd. | 0 |
| 2011-11-24 | NAI | No action indicated | Arjo (Suzhou) Co., Ltd. | 0 |
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