Module 19 2021

02/06/2021

IMDRF codes – medical device problem Level 1 codes

• Infusion or Flow Problem • Activation, Positioning or Separation Problem • Protective Measures Problem • Compatibility Problem • Contamination /Decontamination Problem • Environmental Compatibility Problem • Installation-Related Problem • Labelling, Instructions for Use or Training Problem • Human-Device Interface Problem • Use of Device Problem • Adverse Event Without Identified Device or Use Problem • No Apparent Adverse Event • Insufficient Information • Appropriate Term/Code Not Available

• Patient Device Interaction Problem • Manufacturing, Packaging or Shipping Problem • Chemical Problem • Material Integrity Problem • Mechanical Problem • Optical Problem • Electrical /Electronic Property Problem • Calibration Problem • Output Problem • Temperature Problem • Computer Software Problem • Connection Problem • Communication or Transmission Problem

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FSCA reporting

Definitions

(65) ‘recall’ means any measure aimed at achieving the return of a device that has already been made available to the end user; (66) ‘withdrawal’ means any measure aimed at preventing a device in the supply chain from being further made available on the market; (71) ‘field safety corrective action’ means corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market; (72) ‘field safety notice’ means a communication sent by a manufacturer to users or customers in relation to a field safety corrective action;

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