Device Causes Injury (FDA Maude Events)
DJO (Mexico based manufacturer, brand name TRITON) – Patient injured
DJO (Mexico based manufacturer, brand name TRITON) – Machine malfunctioned
Hollywog, LLC – Patient safety switch absent, screen problems
AXIOM (DRX 9000) – Patient has permanent injury, patients complain details
AXIOM (DRX 9000) – Operator reports error, misassembled device
AXIOM (DRX 9000) – Patient can no longer walk, patient relative reports to FDA
AXIOM (DRX 9000) – Operator reports misassembled device to FDA
Decompression Truth
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