BlueSensor NECG Electrodes · recalls, adverse events, clearances

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.

6 linked reportsInjury 6

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-02	0	1
2019-04	0	1.25
2019-05	0	1
2019-06	0	1
2019-07	0	2
2019-08	0	1
2019-10	0	1.5
2019-12	0	1.25
2020-01	0	1
2020-02	0	1
2020-04	0	1
2020-07	0	1
2020-08	0	1.33
2020-09	0	1
2020-10	0	1
2020-11	0	2.33
2020-12	0	1
2021-01	0	2
2021-02	0	1
2021-03	0	1.33
2021-04	0	2
2021-05	0	2
2021-06	0	1
2021-07	0	2
2021-08	0	1
2021-09	0	1
2021-10	0	2.75
2021-11	0	1.5
2021-12	0	3
2022-02	0	2
2022-03	0	1.5
2022-05	0	2
2022-07	0	1.5
2022-08	0	1.67
2022-09	0	1.43
2022-10	0	1.5
2022-11	0	3.8
2022-12	0	2
2023-01	0	1.8
2023-02	0	2.57
2023-03	0	4
2023-04	0	2.5
2023-05	0	1.36
2023-06	0	2.8
2023-07	0	1.25
2023-08	0	2.17
2023-09	0	3
2023-10	0	1.17
2023-11	0	1.5
2023-12	0	2
2024-01	0	1.2
2024-02	0	2.8
2024-03	0	2.83
2024-04	0	1
2024-05	0	1.67
2024-06	0	1.67
2024-07	0	2
2024-08	0	2
2024-09	0	1.71
2024-11	0	2
2025-01	0	5
2025-02	0	2.5
2025-03	0	1.75
2025-04	0	2
2025-05	0	3
2025-06	0	3
2025-07	6	4.75
2025-08	0	4
2025-09	0	5.33
2025-10	0	9.25
2025-11	0	9
2025-12	0	8
2026-01	0	12
2026-02	0	4.14
2026-03	0	5.5
2026-04	0	4.4
2026-05	0	5.2
2026-06	0	6

This device (reports/month)Average device in DRX (reports/device/month)

Failure-mode summaryAI-generated

6 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2025-07-03	1220828-2025-00017	Injury	Available	catalog number
2025-07-02	9610691-2025-00017	Injury	Available	catalog number

Showing the most recent 2 of 6 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2016-05-20	VAI	Voluntary action indicated	AMBU Limited	0
2016-04-15	VAI	Voluntary action indicated	Ambu Sdn. Bhd.	0
2013-11-07	VAI	Voluntary action indicated	AMBU Limited	2
2013-09-19	VAI	Voluntary action indicated	Ambu Sdn. Bhd.	5
2013-06-19	NAI	No action indicated	Ambu A/S	0
2013-06-19	NAI	No action indicated	Ambu A/S	0
2011-06-02	VAI	Voluntary action indicated	AMBU Limited	2
2010-02-09	NAI	No action indicated	Ambu A/S	0
2010-02-09	NAI	No action indicated	Ambu A/S	0

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