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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(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.)
Attribution 4.0 (CC BY 4.0)https://creativecommons.org/licenses/by/4.0/
License information was derived automatically
Summary of death and injury reports (2000–2012).
Attribution 4.0 (CC BY 4.0)https://creativecommons.org/licenses/by/4.0/
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47 cases from US FDA MAUDE database involving death, cardiotocography, and probable maternal heart rate artefact.
Attribution 4.0 (CC BY 4.0)https://creativecommons.org/licenses/by/4.0/
License information was derived automatically
117 cases from US FDA MAUDE database involving cardiotocography devices and event type death.
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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.