Description of Event or Problem · 1
REPORTER CALLED TO REPORT A PRODUCT ISSUE WITH THE NEURALSCAN EEG AND EVOKED RESPONSE DEVICE. REPORTER STATED SHE DOES NOT BELIEVE THIS DEVICE IS EFFECTIVE AND DOESN'T ALLOW PATIENTS TO BE PROPERLY DIAGNOSED. REPORTER STATED HER FIRST ISSUE WITH THE EEG FUNCTION IS THAT THE PATIENT IS SITTING UP FOR THE EXAM, WHICH DOESN'T ALLOW FOR ACCURATE DATA. REPORTER ALSO STATED THAT THE EEG INTERPRETS ITSELF AND THE DATA IS PRESENTED VERY SQUISHED WITHOUT NORMAL TIME SIGNATURE WHICH MAKES IT UNINTERPRETABLE. REPORTER STATED THAT WHILE THE DEVICE IS LIKELY SAFE, IT DOES NOT DO ANYTHING USEFUL AND DETRACTS FROM PROPER EVALUATION AND DIAGNOSIS. REPORTER STATED THAT THE EVOKED POTENTIALS TEST IS PRESENTED IN A TINY COMPRESSED FORMAT AND THE QUALITY IS HARD TO READ. REPORTER STATED THE EVOKED POTENTIALS TEST IS NOT DONE UNDER PRECISE CONDITIONS LIKE IT SHOULD BE AND DOES NOT BELIEVE THIS DEVICE IS NEEDED FOR DEMENTIA OR ALZHEIMER'S DIAGNOSIS. REPORTER DOESN'T THINK THE DEVICE SHOULD BE USED IN PLACE OF A NORMAL EEG OR EVOKED POTENTIALS BECAUSE IT'S NOT AS HIGH QUALITY AND YOU CAN'T INTERPRET/UNDERSTAND CONDITIONS OR RESULTS. REPORTER STATED THIS DEVICE COULD BE POTENTIALLY INJURING PATIENTS BY USING IT IN PLACE OF A NORMAL, PROPER EEG AND EVOKED POTENTIALS TEST. REPORTER STATED THE FDA APPROVED THE NEURALSCAN DEVICE BECAUSE IT'S SIMILAR ENOUGH TO LIKE DEVICES, BUT THINKS IT NEEDS TO BE REEVALUATED.