Data from: MAUDE (Manufacturer and User Facility Device Experience)
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Updated Jul 11, 2025+ more versions
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EmailClick to copy linkLink copiedCiteU.S. Food and Drug Administration (2025). MAUDE (Manufacturer and User Facility Device Experience) [Dataset]. https://catalog.data.gov/dataset/maude-manufacturer-and-user-facility-device-experienceDataset updatedJul 11, 2025DescriptionMAUDE data represents reports of adverse events involving medical devices. The data consists of all voluntary reports since June, 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August, 1996.
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Related work on analysis of the FDA adverse event reports on robotic...
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xlsUpdated Jun 12, 2023ShareFacebookTwitterEmailClick to copy linkLink copiedCiteHoma Alemzadeh; Jaishankar Raman; Nancy Leveson; Zbigniew Kalbarczyk; Ravishankar K. Iyer (2023). Related work on analysis of the FDA adverse event reports on robotic surgical systems. [Dataset]. http://doi.org/10.1371/journal.pone.0151470.t001xlsAvailable download formatsUnique identifierhttps://doi.org/10.1371/journal.pone.0151470.t001Dataset updatedJun 12, 2023Dataset provided byPLOS ONEAuthorsHoma Alemzadeh; Jaishankar Raman; Nancy Leveson; Zbigniew Kalbarczyk; Ravishankar K. IyerLicenseAttribution 4.0 (CC BY 4.0)https://creativecommons.org/licenses/by/4.0/
License information was derived automaticallyDescriptionRelated work on analysis of the FDA adverse event reports on robotic surgical systems.
Major categories of malfunctions.
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xlsUpdated Jun 5, 2023ShareFacebookTwitterEmailClick to copy linkLink copiedCiteHoma Alemzadeh; Jaishankar Raman; Nancy Leveson; Zbigniew Kalbarczyk; Ravishankar K. Iyer (2023). Major categories of malfunctions. [Dataset]. http://doi.org/10.1371/journal.pone.0151470.t004xlsAvailable download formatsUnique identifierhttps://doi.org/10.1371/journal.pone.0151470.t004Dataset updatedJun 5, 2023AuthorsHoma Alemzadeh; Jaishankar Raman; Nancy Leveson; Zbigniew Kalbarczyk; Ravishankar K. IyerLicenseAttribution 4.0 (CC BY 4.0)https://creativecommons.org/licenses/by/4.0/
License information was derived automaticallyDescription(Note that the malfunction and surgical team action categories are not mutually exclusive, i.e., in many cases more than one malfunction or action were reported in a single event.)
Adverse events in different surgical specialties: Deaths, injuries,...
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xlsUpdated Jun 1, 2023ShareFacebookTwitterEmailClick to copy linkLink copiedCiteHoma Alemzadeh; Jaishankar Raman; Nancy Leveson; Zbigniew Kalbarczyk; Ravishankar K. Iyer (2023). Adverse events in different surgical specialties: Deaths, injuries, malfunctions, procedure conversion or rescheduling, common types of surgery. [Dataset]. http://doi.org/10.1371/journal.pone.0151470.t002xlsAvailable download formatsUnique identifierhttps://doi.org/10.1371/journal.pone.0151470.t002Dataset updatedJun 1, 2023AuthorsHoma Alemzadeh; Jaishankar Raman; Nancy Leveson; Zbigniew Kalbarczyk; Ravishankar K. IyerLicenseAttribution 4.0 (CC BY 4.0)https://creativecommons.org/licenses/by/4.0/
License information was derived automaticallyDescriptionAdverse events in different surgical specialties: Deaths, injuries, malfunctions, procedure conversion or rescheduling, common types of surgery.
47 cases with probable MHRA
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pdfUpdated Dec 6, 2019ShareFacebookTwitterEmailClick to copy linkLink copiedCiteDaniel James Kiely (2019). 47 cases with probable MHRA [Dataset]. http://doi.org/10.6084/m9.figshare.9730172.v1pdfAvailable download formatsUnique identifierhttps://doi.org/10.6084/m9.figshare.9730172.v1Dataset updatedDec 6, 2019AuthorsDaniel James KielyLicenseAttribution 4.0 (CC BY 4.0)https://creativecommons.org/licenses/by/4.0/
License information was derived automaticallyDescription47 cases from US FDA MAUDE database involving death, cardiotocography, and probable maternal heart rate artefact.
Full list of 117 cases of CTG-associated fetal or neonatal deaths
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pdfUpdated Dec 6, 2019ShareFacebookTwitterEmailClick to copy linkLink copiedCiteDaniel James Kiely (2019). Full list of 117 cases of CTG-associated fetal or neonatal deaths [Dataset]. http://doi.org/10.6084/m9.figshare.9730169.v1pdfAvailable download formatsUnique identifierhttps://doi.org/10.6084/m9.figshare.9730169.v1Dataset updatedDec 6, 2019AuthorsDaniel James KielyLicenseAttribution 4.0 (CC BY 4.0)https://creativecommons.org/licenses/by/4.0/
License information was derived automaticallyDescription117 cases from US FDA MAUDE database involving cardiotocography devices and event type death.
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FacebookTwitterEmailMAUDE data represents reports of adverse events involving medical devices. The data consists of all voluntary reports since June, 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August, 1996.