Dynatronics Dynatron 550 Plus - Medical Device Reporting Requirements; Reporting any Incident of Patient Discomfort

Dynatron® 850plus & 550plus
Service
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When the electrode is connected to a patient lead wire as shown in the diagram above, the
stereo jack at the opposite end of the lead wire prevents connection of the cable to any power
source other than a stereo jack as found on Dynatronics devices. The stereo connector is 1/4”
in diameter and cannot be inserted directly into an AC power source. NOTE: As of May 9,
2000 new FDA compliant lead wires are available from Dynatronics and are included
with all new devices.
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 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 10 working days.
• 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).
Reporting any Incident of Patient Discomfort
Dynatronics recommends that if discomfort of any level is reported by the patient, the
treatment be stopped immediately. The device and all accessories in use during that
treatment should be isolated and held for inspection. Make a note of treatment parameters
that were in use during the treatment including intensity settings. Also note environmental
factors that were observed during the treatment (office lights flickering, static electricity
discharge, other devices in use on the same power source or in the same room, etc.)
The incident should be reported immediately to Dynatronics Customer Service at 1-800-874-
6251. The customer service representative will inform you if it is necessary to send the
device and/or accessories to Dynatronics for inspection.