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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.

4 linked reportsMalfunction 3Death 1
61218242019-01: 0 reports for this device; peer average 8.07/device2019-02: 0 reports for this device; peer average 2.73/device2019-03: 0 reports for this device; peer average 4/device2019-04: 0 reports for this device; peer average 3.67/device2019-05: 0 reports for this device; peer average 5.74/device2019-06: 0 reports for this device; peer average 4.87/device2019-07: 0 reports for this device; peer average 7.26/device2019-08: 0 reports for this device; peer average 6.92/device2019-09: 0 reports for this device; peer average 6.77/device2019-10: 0 reports for this device; peer average 8.24/device2019-11: 0 reports for this device; peer average 9.4/device2019-12: 0 reports for this device; peer average 6.33/device2020-01: 0 reports for this device; peer average 5.84/device2020-02: 0 reports for this device; peer average 7.47/device2020-03: 0 reports for this device; peer average 5.73/device2020-04: 0 reports for this device; peer average 6.16/device2020-05: 0 reports for this device; peer average 4.85/device2020-06: 0 reports for this device; peer average 6.05/device2020-07: 0 reports for this device; peer average 7.95/device2020-08: 0 reports for this device; peer average 6.22/device2020-09: 0 reports for this device; peer average 7.08/device2020-10: 0 reports for this device; peer average 5.39/device2020-11: 0 reports for this device; peer average 9.22/device2020-12: 0 reports for this device; peer average 9.6/device2021-01: 0 reports for this device; peer average 6.13/device2021-02: 0 reports for this device; peer average 10.29/device2021-03: 0 reports for this device; peer average 14.31/device2021-04: 0 reports for this device; peer average 18.59/device2021-05: 0 reports for this device; peer average 11.03/device2021-06: 0 reports for this device; peer average 12.86/device2021-07: 0 reports for this device; peer average 15.92/device2021-08: 0 reports for this device; peer average 18.12/device2021-09: 0 reports for this device; peer average 12.52/device2021-10: 0 reports for this device; peer average 12.73/device2021-11: 0 reports for this device; peer average 11.77/device2021-12: 0 reports for this device; peer average 13.28/device2022-01: 0 reports for this device; peer average 8.79/device2022-02: 0 reports for this device; peer average 9.71/device2022-03: 0 reports for this device; peer average 9.32/device2022-04: 0 reports for this device; peer average 7.18/device2022-05: 0 reports for this device; peer average 9.26/device2022-06: 0 reports for this device; peer average 5/device2022-07: 0 reports for this device; peer average 8.5/device2022-08: 0 reports for this device; peer average 8.4/device2022-09: 0 reports for this device; peer average 4.08/device2022-10: 0 reports for this device; peer average 4.85/device2022-11: 0 reports for this device; peer average 6.86/device2022-12: 0 reports for this device; peer average 6.34/device2023-01: 0 reports for this device; peer average 6.31/device2023-02: 0 reports for this device; peer average 7.55/device2023-03: 0 reports for this device; peer average 16.15/device2023-04: 0 reports for this device; peer average 11.67/device2023-05: 0 reports for this device; peer average 11.62/device2023-06: 0 reports for this device; peer average 10.37/device2023-07: 1 reports for this device; peer average 9.83/device2023-08: 0 reports for this device; peer average 9.53/device2023-09: 0 reports for this device; peer average 14.33/device2023-10: 0 reports for this device; peer average 10.53/device2023-11: 0 reports for this device; peer average 7.92/device2023-12: 0 reports for this device; peer average 12.07/device2024-01: 0 reports for this device; peer average 8.63/device2024-02: 0 reports for this device; peer average 11.08/device2024-03: 0 reports for this device; peer average 12.58/device2024-04: 0 reports for this device; peer average 9.02/device2024-05: 1 reports for this device; peer average 10.2/device2024-06: 0 reports for this device; peer average 9.88/device2024-07: 0 reports for this device; peer average 8.36/device2024-08: 0 reports for this device; peer average 11.2/device2024-09: 0 reports for this device; peer average 9.38/device2024-10: 1 reports for this device; peer average 12.55/device2024-11: 0 reports for this device; peer average 11.68/device2024-12: 0 reports for this device; peer average 10.27/device2025-01: 0 reports for this device; peer average 12.54/device2025-02: 0 reports for this device; peer average 11.46/device2025-03: 0 reports for this device; peer average 16.37/device2025-04: 0 reports for this device; peer average 13/device2025-05: 0 reports for this device; peer average 13.62/device2025-06: 0 reports for this device; peer average 16.23/device2025-07: 0 reports for this device; peer average 18.92/device2025-08: 0 reports for this device; peer average 13.56/device2025-09: 0 reports for this device; peer average 13.69/device2025-10: 0 reports for this device; peer average 22.11/device2025-11: 1 reports for this device; peer average 15.64/device2025-12: 0 reports for this device; peer average 18.23/device2026-01: 0 reports for this device; peer average 17.16/device2026-02: 0 reports for this device; peer average 22.52/device2026-03: 0 reports for this device; peer average 22.05/device2026-04: 0 reports for this device; peer average 19.73/device2026-05: 0 reports for this device; peer average 23.7/device2026-06: 0 reports for this device; peer average 21.32/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0108.07
2019-0202.73
2019-0304
2019-0403.67
2019-0505.74
2019-0604.87
2019-0707.26
2019-0806.92
2019-0906.77
2019-1008.24
2019-1109.4
2019-1206.33
2020-0105.84
2020-0207.47
2020-0305.73
2020-0406.16
2020-0504.85
2020-0606.05
2020-0707.95
2020-0806.22
2020-0907.08
2020-1005.39
2020-1109.22
2020-1209.6
2021-0106.13
2021-02010.29
2021-03014.31
2021-04018.59
2021-05011.03
2021-06012.86
2021-07015.92
2021-08018.12
2021-09012.52
2021-10012.73
2021-11011.77
2021-12013.28
2022-0108.79
2022-0209.71
2022-0309.32
2022-0407.18
2022-0509.26
2022-0605
2022-0708.5
2022-0808.4
2022-0904.08
2022-1004.85
2022-1106.86
2022-1206.34
2023-0106.31
2023-0207.55
2023-03016.15
2023-04011.67
2023-05011.62
2023-06010.37
2023-0719.83
2023-0809.53
2023-09014.33
2023-10010.53
2023-1107.92
2023-12012.07
2024-0108.63
2024-02011.08
2024-03012.58
2024-0409.02
2024-05110.2
2024-0609.88
2024-0708.36
2024-08011.2
2024-0909.38
2024-10112.55
2024-11011.68
2024-12010.27
2025-01012.54
2025-02011.46
2025-03016.37
2025-04013
2025-05013.62
2025-06016.23
2025-07018.92
2025-08013.56
2025-09013.69
2025-10022.11
2025-11115.64
2025-12018.23
2026-01017.16
2026-02022.52
2026-03022.05
2026-04019.73
2026-05023.7
2026-06021.32
This device (reports/month)Average device in MHX (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2022-03-04Z-1012-2022Class IIOpen, ClassifiedSoftware issue resulting in temporary loss of central monitoring functionality.Distribution: Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, IA, ID, IL, IN, LA, MN, MS, NC, NE, NH, NY, OH, PA, SD, TN, TX, WA, WI, and 58 additional foreign countries.1950 (1574 OUS + 376 US)clearance family
2019-10-09Z-0372-2020Class IIOpen, ClassifiedThe devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering.Distribution: US nationwide distribution.12204clearance family
Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2025-11-101220063-2025-00057MalfunctionAvailableexact di
2024-10-311220063-2024-00126MalfunctionAvailableexact di
2024-05-201220063-2024-00059MalfunctionAvailableexact di
2023-07-291220063-2023-00026DeathAvailableexact di
Regulatory clearances
  • 510(k)K130711Substantially equivalent (SESE) · 2013-04-11clearance family

Predicate lineage

Cited as predicate by: K151860, K200859

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
DateTypeOutcomeFacilityCitations
2024-11-27NAINo action indicatedDraeger Medical Systems, Inc.0
2024-11-27NAINo action indicatedDraeger Medical Systems, Inc.0
2022-08-15NAINo action indicatedDraeger Medical Systems, Inc.0
2022-08-15NAINo action indicatedDraeger Medical Systems, Inc.0
2022-04-21VAIVoluntary action indicatedDraeger Medical Systems, Inc.2
2022-04-21VAIVoluntary action indicatedDraeger Medical Systems, Inc.2
2020-01-17WLWarning LetterDraeger Medical Systems, Inc.—
2020-01-17WLWarning LetterDraeger Medical Systems, Inc.—
2019-09-20OAIOfficial action indicatedDraeger Medical Systems, Inc.0
2019-09-20OAIOfficial action indicatedDraeger Medical Systems, Inc.0
2013-07-03VAIVoluntary action indicatedDraeger Medical Systems, Inc.1
2013-07-03VAIVoluntary action indicatedDraeger Medical Systems, Inc.1
2013-04-12VAIVoluntary action indicatedDraeger Medical Systems, Inc.0
2013-04-12VAIVoluntary action indicatedDraeger Medical Systems, Inc.0
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