Dynatronics Dynatron 525, Руководство оператора

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medICal deVICe rePorTIng requIremenTs
DYNATRON® 25 SERIES™ | OPERATOR’S MANUAL 100
Medical Device
Reporting Requirements
Under the Safe Medical Devices Act (SMDA), the manufacturer and distributor are required to report specific incidents to the
FDA. In the event of any applicable incident, you should report details of the incident to the Dynatronics Customer Service
Department at 1-800-874-6251. Reports should be submitted to the manufacturer immediately to allow the manufacturer to
report to the FDA within 2 working days based on the following criteria:
• If you receive information that reasonably suggests a probability that a device caused or contributed to a:
• death
• serious injury, or
• serious illness
• If you receive information that reasonably suggests a device malfunction and a recurrence will probably cause:
• death
• serious injury, or
• serious illness
Definition of serious injury
A “serious injury” is an injury that (1) is life threatening, (2) results in permanent impairment of a body function or permanent
damage to body structure, or (3) necessitates medical or surgical intervention by a health care professional to (i) preclude
permanent impairment of a body function or permanent damage to body structure or (ii) relieve unanticipated temporary
impairment of a body function or unanticipated temporary damage to a body structure.
Reference: Food and Drug Administration, HHS. 21 CFR Ch. 1 (4-1-90 Edition), 803.9 (h).