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Adverse Event Report

ANODYNE THERAPEUTICS, LLC ANODYNE INFRARED THERAPY DEVICE   back to search results
Model Number 480
Event Description

Defective product. Engineer was actually shocked as a result of defect in product. Evaluation/safety issues: unit under test uut. 1. 120 volts ac on phono plug connector for led pads. Problem: power switch is touching transformer secondary. During assembly, if heat shrink (insulating layer) is punctured, then ac power from the power switch is connected to center tap of transformer secondary. This puts voltage from the wall outlet directly into the electrical connections for the led pads. Test: to test for this problem, use an ac meter to read 120vac between phono plug and safety ground. 2. Safety ground is not connected to case of uut. Problem: in assembly, the safety ground lead in the ac power cord was not connected to the uut case. 3. Uut is not using a "medical isolation" transformer. 4. Brass machine screws holding case together are too long. One of four, half inch brass screws is within 1/16 inch of phono plug which could short against phono plug.

 
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Brand NameANODYNE
Type of DeviceINFRARED THERAPY DEVICE
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
ANODYNE THERAPEUTICS, LLC
2100 s. dayton st.
denver CO 80231 5733
Device Event Key233749
MDR Report Key241257
Event Key226362
Report NumberMW4002610
Device Sequence Number1
Product CodeILY
Report Source Voluntary
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/31/1999
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Other
Device MODEL Number480
Was Device Available For Evaluation? Yes
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on January 30, 2009

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