# openFDA Device Event Review Workload Brief (`jpmarketdata/openfda-device-event-workload-brief`) Actor

Monthly MAUDE report review workload for up to five exact FDA device product codes, with event-type counts and five source-linked report IDs per code. Reports are not device failure rates or evidence of causation.

- **URL**: https://apify.com/jpmarketdata/openfda-device-event-workload-brief.md
- **Developed by:** [h ichi](https://apify.com/jpmarketdata) (community)
- **Categories:** Automation, News
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

$5.00 / 1,000 device code brief createds

This Actor is paid per event. You are not charged for the Apify platform usage, but only a fixed price for specific events.

Learn more: https://docs.apify.com/actors/running/actors-in-store.md#pay-per-event

## What's an Apify Actor?

An Actor is a serverless cloud program that runs on the Apify platform. It has two run modes.
In Batch mode, an Actor accepts a well-defined JSON input, performs an action which can take anything from a few seconds to a few hours,
and optionally produces a well-defined JSON output, datasets with results, or files in key-value store.
In Standby mode, an Actor provides a web server which can be used as a website, API, or an MCP server.

Apify vocabulary and the platform model are defined once, in the agent quickstart at https://apify.com/agents.md.

## How to integrate an Actor?

If asked about integration, you help developers integrate Actors into their projects.
You adapt to their stack and deliver integrations that are safe, well-documented, and production-ready.

Do not guess an integration path. Every one of them is in the agent quickstart at https://apify.com/agents.md: the Apify MCP server, Agent Skills with the Apify CLI, the JavaScript and Python clients, the REST API, and the account-free path for an agent with no human to sign in. It also carries the rule on stating cost before the first paid run.

For examples already wired to this Actor's own input schema, see the [API](#api) section below.

Each client library has reference documentation the quickstart does not restate: [JavaScript/TypeScript](https://docs.apify.com/api/client/js/docs.md) (`npm install apify-client`) and [Python](https://docs.apify.com/api/client/python/docs.md) (`pip install apify-client`).

# README

## openFDA Device Event Review Workload Brief

For a medical-device quality or regulatory reviewer, this brief counts FDA MAUDE adverse-event reports received in the latest complete calendar month available from openFDA and the preceding month, for one to five exact three-letter device product codes. It includes up to five recent report IDs per code to open in FDA source data. This is a report-intake and human-review queue aid, not a device safety ranking, failure rate, clinical recommendation, causal finding or regulatory conclusion. FDA reports can be incomplete, late, duplicated or revised.

### Input

`productCodes` accepts one to five uppercase three-letter FDA product codes, default `LKK` and `NRY`. Each code is checked against FDA device classification before counting. The Actor reads `meta.last_updated` and chooses the latest complete calendar month before the refresh month, plus the preceding month. It does not use a partial current month.

### Output

One row per validated code includes FDA generic device name, source refresh date, two YYYY-MM month windows, total report counts, event-type count dictionaries, absolute count difference, and up to five recent report keys, received dates, coded event types and FDA links. A confirmed zero-month count is a real negative report-intake observation, not a safety claim. Report counts must never be interpreted as incidence, prevalence, comparative safety or causation. Rows are not risk ranked. No patient, reporter or manufacturer contact, narrative or raw source body is retained.

### Pricing

One `device-code-brief-created` PPE event at $0.005 per delivered row, including a validated zero-month brief. A two-code default produces two dataset rows and two primary events for $0.010; no start or secondary event. Any failed classification/source request prevents all output and charge.

### Limits

At most five codes and 21 HTTPS requests; 256 MB, 180 seconds, 20-second per-request timeout, sequential at least one second apart, no browser, proxy, paid API or key. FDA no-key quotas apply to the shared egress IP. Only exact structured `NOT_FOUND / No matches found!` for a validated code and month means zero; 401/403, 429, 5xx, unexpected 404, malformed JSON, changed count shape or timeout fails explicitly. Source counts may change as FDA updates reports. FDA/openFDA are the source; this Actor is unaffiliated with FDA.

### Privacy

Only the FDA product code, generic device name, grouped counts, refresh date, and up to five report keys/dates/coded types/source links are returned. Patient demographics, narratives, reporter identities, manufacturer contacts, addresses, raw JSON and logs of source bodies are omitted.

# Actor input Schema

## `productCodes` (type: `array`):

One to five exact three-letter FDA device product codes. Defaults LKK (implanted infusion pump) and NRY (thrombus-retriever catheter).

## Actor input object example

```json
{
  "productCodes": [
    "LKK",
    "NRY"
  ]
}
```

# Actor output Schema

## `results` (type: `string`):

No description

# API

You can run this Actor programmatically using our API. Below are code examples in JavaScript, Python, and CLI, as well as the OpenAPI specification and MCP server setup.

## JavaScript example

```javascript
import { ApifyClient } from 'apify-client';

// Initialize the ApifyClient with your Apify API token
// Replace the '<YOUR_API_TOKEN>' with your token
const client = new ApifyClient({
    token: '<YOUR_API_TOKEN>',
});

// Prepare Actor input
const input = {};

// Run the Actor and wait for it to finish
const run = await client.actor("jpmarketdata/openfda-device-event-workload-brief").call(input);

// Fetch and print Actor results from the run's dataset (if any)
console.log('Results from dataset');
console.log(`💾 Check your data here: https://console.apify.com/storage/datasets/${run.defaultDatasetId}`);
const { items } = await client.dataset(run.defaultDatasetId).listItems();
items.forEach((item) => {
    console.dir(item);
});

// 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/js/docs

```

## Python example

```python
from apify_client import ApifyClient

# Initialize the ApifyClient with your Apify API token
# Replace '<YOUR_API_TOKEN>' with your token.
client = ApifyClient("<YOUR_API_TOKEN>")

# Prepare the Actor input
run_input = {}

# Run the Actor and wait for it to finish
run = client.actor("jpmarketdata/openfda-device-event-workload-brief").call(run_input=run_input)

# Fetch and print Actor results from the run's dataset (if there are any)
print(f"💾 Check your data here: https://console.apify.com/storage/datasets/{run.default_dataset_id}")
for item in client.dataset(run.default_dataset_id).iterate_items():
    print(item)

# 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/python/docs/quick-start

```

## CLI example

```bash
echo '{}' |
apify call jpmarketdata/openfda-device-event-workload-brief --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,jpmarketdata/openfda-device-event-workload-brief"
        }
    }
}
```

The hosted server signs you in with OAuth on first connect, so no API token belongs in this config. Clients without OAuth support can send an `Authorization: Bearer <APIFY_API_TOKEN>` header instead, using a token from API & Integrations in Apify Console (https://console.apify.com/settings/integrations).

## OpenAPI specification

Download the OpenAPI definition: https://api.apify.com/v2/actors/4BybEimfiiWwvEiwy/builds/q8ED30w9AHdZXcy8v/openapi.json
