Dynatron 150plus, Руководство по обслуживанию

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Dynatron ® 150 plus
Medical Device Reporting
51
Medical Device Reporting Requirements
Under the Safe Medical Devices Act (SMDA) of November 1990, 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
the time requested.
• 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: 21 CFR Part 803
Schematics and QC Check Lists
The following pages provide the schematics and QC check lists for the Dynatron 125.