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 StatesNIMBUS PROFESSIONAL05055982782210
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) |
|---|---|---|
| 2023-04 | 1 | — |
| 2025-07 | 1 | — |
Failure-mode summaryAI-generated
2 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-07-11 | 3005619970-2025-00029 | Malfunction | Available | exact di |
| 2023-04-18 | 3005619970-2023-00006 | Malfunction | 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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