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.
3 linked reportsMalfunction 3
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2020-03 | 0 | 1 |
| 2020-06 | 0 | 1 |
| 2020-07 | 0 | 1 |
| 2021-03 | 2 | 2 |
| 2021-10 | 0 | 2 |
| 2021-12 | 0 | 2 |
| 2022-01 | 0 | 2 |
| 2022-05 | 0 | 1 |
| 2022-09 | 1 | 1 |
| 2023-01 | 0 | 1 |
| 2023-02 | 0 | 1 |
| 2023-07 | 0 | 2 |
| 2023-08 | 0 | 1 |
| 2023-12 | 0 | 1 |
| 2024-01 | 0 | 4 |
| 2024-03 | 0 | 2 |
| 2024-08 | 0 | 9 |
| 2025-01 | 0 | 2 |
| 2025-02 | 0 | 2 |
| 2025-03 | 0 | 2 |
| 2025-05 | 0 | 2 |
| 2025-07 | 0 | 6 |
| 2025-10 | 0 | 2 |
| 2025-11 | 0 | 6 |
| 2025-12 | 0 | 2 |
| 2026-01 | 0 | 6 |
Failure-mode summaryAI-generated
3 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2022-09-30 | 15515007 | Malfunction | Available | catalog number |
| 2021-03-03 | 11403863 | Malfunction | Available | catalog number |
| 2021-03-03 | 11403868 | Malfunction | Available | catalog number |
Regulatory clearances
- 510(k)K222331Substantially equivalent (SESE) · 2022-09-14clearance family
- 510(k)K203839Substantially equivalent (SESE) · 2022-03-21clearance family
- 510(k)K180775Substantially equivalent (SESE) · 2018-08-17clearance family
Predicate lineage
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2019-12-19 | VAI | Voluntary action indicated | Itamar Medical Ltd. | 1 |
| 2019-12-19 | VAI | Voluntary action indicated | Itamar Medical Ltd. | 1 |
| 2011-01-13 | VAI | Voluntary action indicated | Itamar Medical Ltd. | 0 |
| 2011-01-13 | VAI | Voluntary action indicated | Itamar Medical Ltd. | 0 |
Similar devices
- "ezRIP, thorax, 1.5, 84"", Alice 5" Respironics, Inc.
- 1 channel ECG sensor SOMNOmedics AG
- 1 channel ECG sensor including body position and disposable electrodes SOMNOmedics AG
- 1-channel ECG Electrode SOMNOmedics AG
- 1-channel EEG option for SOMNOtouch RESP SOMNOmedics AG
- 1-channel analogue optocoupler SOMNOmedics AG
- 3-channel ECG sensor SOMNOmedics AG
- 32-channel EEG Headbox for SOMNO HD SOMNOmedics AG
- 4-channel analogue optocoupler for SOMNO HD SOMNOmedics AG
- AASM Headbox SOMNOmedics AG
- AIRVIEW RESMED PTY LTD
- ALICE 4 Respironics, Inc.
Select up to two to place side-by-side with this device.