5 datasets found
  1. Data from: MAUDE (Manufacturer and User Facility Device Experience)

    • healthdata.gov
    • data.virginia.gov
    • +4more
    application/rdfxml +5
    Updated Feb 25, 2021
    + more versions
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    open.fda.gov (2021). MAUDE (Manufacturer and User Facility Device Experience) [Dataset]. https://healthdata.gov/dataset/MAUDE-Manufacturer-and-User-Facility-Device-Experi/u4i2-5xvt
    Explore at:
    csv, application/rssxml, json, tsv, application/rdfxml, xmlAvailable download formats
    Dataset updated
    Feb 25, 2021
    Dataset provided by
    open.fda.gov
    Description

    MAUDE 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.

  2. f

    Major categories of malfunctions.

    • plos.figshare.com
    xls
    Updated Jun 5, 2023
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    Homa Alemzadeh; Jaishankar Raman; Nancy Leveson; Zbigniew Kalbarczyk; Ravishankar K. Iyer (2023). Major categories of malfunctions. [Dataset]. http://doi.org/10.1371/journal.pone.0151470.t004
    Explore at:
    xlsAvailable download formats
    Dataset updated
    Jun 5, 2023
    Dataset provided by
    PLOS ONE
    Authors
    Homa Alemzadeh; Jaishankar Raman; Nancy Leveson; Zbigniew Kalbarczyk; Ravishankar K. Iyer
    License

    Attribution 4.0 (CC BY 4.0)https://creativecommons.org/licenses/by/4.0/
    License information was derived automatically

    Description

    (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.)

  3. Summary of death and injury reports (2000–2012).

    • plos.figshare.com
    xls
    Updated Jun 3, 2023
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    Homa Alemzadeh; Jaishankar Raman; Nancy Leveson; Zbigniew Kalbarczyk; Ravishankar K. Iyer (2023). Summary of death and injury reports (2000–2012). [Dataset]. http://doi.org/10.1371/journal.pone.0151470.t005
    Explore at:
    xlsAvailable download formats
    Dataset updated
    Jun 3, 2023
    Dataset provided by
    PLOShttp://plos.org/
    Authors
    Homa Alemzadeh; Jaishankar Raman; Nancy Leveson; Zbigniew Kalbarczyk; Ravishankar K. Iyer
    License

    Attribution 4.0 (CC BY 4.0)https://creativecommons.org/licenses/by/4.0/
    License information was derived automatically

    Description

    Summary of death and injury reports (2000–2012).

  4. 47 cases with probable MHRA

    • figshare.com
    pdf
    Updated Dec 6, 2019
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    Daniel James Kiely (2019). 47 cases with probable MHRA [Dataset]. http://doi.org/10.6084/m9.figshare.9730172.v1
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    pdfAvailable download formats
    Dataset updated
    Dec 6, 2019
    Dataset provided by
    figshare
    Figsharehttp://figshare.com/
    Authors
    Daniel James Kiely
    License

    Attribution 4.0 (CC BY 4.0)https://creativecommons.org/licenses/by/4.0/
    License information was derived automatically

    Description

    47 cases from US FDA MAUDE database involving death, cardiotocography, and probable maternal heart rate artefact.

  5. Full list of 117 cases of CTG-associated fetal or neonatal deaths

    • figshare.com
    pdf
    Updated Dec 6, 2019
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    Daniel James Kiely (2019). Full list of 117 cases of CTG-associated fetal or neonatal deaths [Dataset]. http://doi.org/10.6084/m9.figshare.9730169.v1
    Explore at:
    pdfAvailable download formats
    Dataset updated
    Dec 6, 2019
    Dataset provided by
    figshare
    Authors
    Daniel James Kiely
    License

    Attribution 4.0 (CC BY 4.0)https://creativecommons.org/licenses/by/4.0/
    License information was derived automatically

    Description

    117 cases from US FDA MAUDE database involving cardiotocography devices and event type death.

  6. Not seeing a result you expected?
    Learn how you can add new datasets to our index.

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open.fda.gov (2021). MAUDE (Manufacturer and User Facility Device Experience) [Dataset]. https://healthdata.gov/dataset/MAUDE-Manufacturer-and-User-Facility-Device-Experi/u4i2-5xvt
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Data from: MAUDE (Manufacturer and User Facility Device Experience)

Related Article
Explore at:
csv, application/rssxml, json, tsv, application/rdfxml, xmlAvailable download formats
Dataset updated
Feb 25, 2021
Dataset provided by
open.fda.gov
Description

MAUDE 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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