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.
1 linked reportMalfunction 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2 |
| 2019-06 | 0 | 1 |
| 2022-02 | 0 | 2 |
| 2022-10 | 0 | 1 |
| 2022-11 | 0 | 1 |
| 2022-12 | 0 | 1 |
| 2024-04 | 0 | 2 |
| 2024-06 | 0 | 2 |
| 2025-01 | 1 | 1 |
| 2025-08 | 0 | 1.5 |
| 2025-09 | 0 | 1 |
| 2025-10 | 0 | 2 |
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-01-10 | 2518422-2025-100390 | Malfunction | Available | procode brand trgm |
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2023-02-14 | OAI | Official action indicated | Respironics, Inc. | 1 |
| 2016-12-07 | NAI | No action indicated | Respironics, Inc. | 0 |
| 2015-01-28 | NAI | No action indicated | Respironics, Inc. | 0 |
| 2012-06-15 | NAI | No action indicated | Respironics, Inc. | 0 |
| 2010-09-01 | NAI | No action indicated | Respironics, Inc. | 0 |
| 2010-06-22 | NAI | No action indicated | Respironics, Inc. | 0 |
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