Medical Device Malfunction Definition

Medical Device Reporting (MDR): How to Report Medical …

https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems

Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to...

Attachment C: Summary of MDR Reporting …

https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/attachment-c-summary-mdr-reporting-requirements

MDR Adverse Event Codes | FDA

https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/mdr-adverse-event-codes

The FDA Medical Device Report (MDR) adverse event codes are collectively a system of codes, terms, and definitions used to describe and categorize medical device adverse …

CFR - Code of Federal Regulations Title 21 - Food and …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=803&showFR=1

(k) Malfunction means the failure of a device to meet its performance specifications or otherwise perform as intended. Performance specifications include all …

Adverse Event Terminology - International Medical …

https://www.imdrf.org/working-groups/adverse-event-terminology

improve, harmonize and where necessary expand the terminology and systems being used to code information relating to medical device adverse events, and …

Seven serious medical device malfunctions …

https://www.nsmedicaldevices.com/analysis/medical-device-failures-fda-recalls/

Medical device failures can have adverse consequences for healthcare professionals, as well as patients, in certain cases. Class I medical device recalls …

How to Approach Medical Device Failures | ONS Voice

https://voice.ons.org/news-and-views/when-function-becomes-malfunction

Malfunctioning medical products can pose safety risks to both patients and nurses and waste valuable time and resources. All medical devices and equipment used …

Medical Device Malfunction Definition | Law Insider

https://www.lawinsider.com/dictionary/medical-device-malfunction

Medical Device Malfunction means the failure of a device to meet its performance specifications or otherwise perform as intended. If a medical device detects an …

GUIDELINES ON MEDICAL DEVICES CLINICAL …

https://ec.europa.eu/docsroom/documents/16477/attachments/1/translations/en/renditions/pdf

Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons …

MDR - Article 2 - Definitions - Medical Device Regulation

https://www.medical-device-regulation.eu/2019/07/10/mdr-article-2-definitions/

devices for the control or support of conception; —. products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1 …