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ADVANCED CENTRAL MONITORING STATION
Model CMS-2000 · ADVANCED INSTRUMENTATIONS, INC. · DI B510CMS20001
MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) · Class II · 21 CFR 870.1025
UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): 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 is a reporting baseline (average device in the same product code), not a risk measure.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
8.07
2019-02
0
2.73
2019-03
0
4
2019-04
0
3.67
2019-05
0
5.74
2019-06
0
4.87
2019-07
0
7.26
2019-08
0
6.92
2019-09
0
6.77
2019-10
0
8.24
2019-11
0
9.4
2019-12
0
6.33
2020-01
0
5.84
2020-02
0
7.47
2020-03
0
5.73
2020-04
0
6.16
2020-05
0
4.85
2020-06
0
6.05
2020-07
0
7.95
2020-08
0
6.22
2020-09
0
7.08
2020-10
0
5.39
2020-11
0
9.22
2020-12
0
9.6
2021-01
0
6.13
2021-02
0
10.29
2021-03
0
14.31
2021-04
0
18.59
2021-05
0
11.03
2021-06
0
12.86
2021-07
0
15.92
2021-08
0
18.12
2021-09
0
12.52
2021-10
0
12.73
2021-11
0
11.77
2021-12
0
13.28
2022-01
0
8.79
2022-02
0
9.71
2022-03
0
9.32
2022-04
0
7.18
2022-05
0
9.26
2022-06
0
5
2022-07
0
8.5
2022-08
0
8.4
2022-09
0
4.08
2022-10
0
4.85
2022-11
0
6.86
2022-12
0
6.34
2023-01
0
6.31
2023-02
0
7.55
2023-03
0
16.15
2023-04
0
11.67
2023-05
0
11.62
2023-06
0
10.37
2023-07
0
9.83
2023-08
0
9.53
2023-09
0
14.33
2023-10
0
10.53
2023-11
0
7.92
2023-12
0
12.07
2024-01
0
8.63
2024-02
0
11.08
2024-03
0
12.58
2024-04
0
9.02
2024-05
0
10.2
2024-06
0
9.88
2024-07
0
8.36
2024-08
0
11.2
2024-09
0
9.38
2024-10
0
12.55
2024-11
0
11.68
2024-12
0
10.27
2025-01
0
12.54
2025-02
0
11.46
2025-03
0
16.37
2025-04
0
13
2025-05
0
13.62
2025-06
0
16.23
2025-07
0
18.92
2025-08
0
13.56
2025-09
0
13.69
2025-10
0
22.11
2025-11
0
15.64
2025-12
0
18.23
2026-01
0
17.16
2026-02
0
22.52
2026-03
0
22.05
2026-04
0
19.73
2026-05
0
23.7
2026-06
0
21.32
This device (reports/month)Average device in MHX (reports/device/month)