Order №4513
MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION
FEDERAL SERVICE FOR SURVEILLANCE IN HEALTHCARE
ORDER
dated 20 May 2021 N 4513
ON APPROVAL OF THE CLASSIFICATION
OF ADVERSE EVENTS RELATED TO THE CIRCULATION
OF MEDICAL DEVICES
In accordance with part 1 of Article 96 of Federal Law dated 21.11.2011 N 323-FL “On the Fundamentals of Health Protection of Citizens in the Russian Federation” (Collection of Legislation of the Russian Federation, 2011, N 48, Art. 6724; Official Internet Portal of Legal Information http://pravo.gov.ru. 30.04.2021), I hereby order:
To approve the attached classification of adverse events related to the circulation of medical devices.
Head
A.V.SAMOYLOVA
Appendix
to the Order of Roszdravnadzor
dated 20.05.2021 N 4513
CLASSIFICATION
OF ADVERSE EVENTS RELATED TO THE CIRCULATION
OF MEDICAL DEVICES
| Adverse events | Code |
| Incompatibility of the intended purpose and performance characteristics of the medical device recommended by the manufacturer with the age, sex, weight, height or other parameters of the patient | А01 |
| Deviation from the design parameters of the medical device occurring during production, manufacture, packaging or delivery | А02 |
| Deviation from the design parameters of the medical device, (chemical characteristics), occurring during production, packaging or delivery | А03 |
| Deviation from the design parameters of the medical device concerning the reliability of the materials used in its production | А04 |
| Unforeseen mechanical effect of the medical device on the patient | А05 |
| Unsatisfactory quality of the transmitted image affecting the operation of the medical device | А06 |
| Malfunction of the electrical circuit of the medical device | А07 |
| Disruption of the calibration of the medical device affecting its accuracy | А08 |
| Deviation from the technical documentation of the medical device affecting the data transmitted by the medical device | А09 |
| Deviation from the operating temperature regime of the medical device leading to its overheating or overcooling | А10 |
| Negative effect of program code or software on the operation of the medical device | А11 |
| Incorrect connection of the medical device or its functional units to systems for the supply of liquids, gases, electricity or for data transmission | А12 |
| Failures in sending or receiving signals, or data between internal components of the medical device | А13 |
| Defects in the circulation of liquid or gases in the medical device (including the vacuum generation process) | А14 |
| Deviation from the design parameters of the medical device leading to a disruption of the sequence of events for activating or placing the medical device in a specific position or disconnecting it | А15 |
| Deviation from the design parameters of the medical device intended to reduce risks or maintain an acceptable level of risks for the patient or operator | А16 |
| Individual intolerance of the medical device by the patient | А17 |
| The presence of any foreign substance not provided for in the technical documentation in the medical device, on its surface or in the packaging, which may affect the efficiency of operation of the medical device or its use for its intended purpose, or which jeopardizes the effectiveness of disinfection of the medical device | А18 |
| Non-compliance of the environment with the conditions provided for in the technical documentation for the operation or storage of the medical device | А19 |
| Incorrect installation, adjustment of the medical device or its configurations | А20 |
| Labelling, instructions for use and documentation on training and maintenance of the medical device that do not correspond to the medical device | А21 |
| A result of the effect of the medical device on the patient not provided for by the manufacturer or operator | А22 |
| Errors in the maintenance, operation of the medical device that violate the manufacturer’s recommendations | А23 |
| An event not related to the medical device | А24 |