COGNIVUE COMPUTERIZED COGNITIVE ASSESSMENT AID

Description of Event or Problem

DEVICE STARTED SMOKING WITH CUSTOMER AND NO ACTION WAS TAKEN. POOR DOCUMENTATION SUCH AS INCOMPLETE SIGNATURES, USE OF RED PEN, NOT INITIAL AND DATING MISTAKES NON-CONFORMING PRODUCT IS PUT UPSTAIRS HIDDEN AND NOT DEALT WITH IN THE CORRECT WAY, BIRDS CONSISTENTLY GET IN FACILITY AND DEFECATE ON THE WALLS, AND DEVICES WERE SENT TO THE UK WITHOUT PROPER UKCA MARK ON LABELS. LABELS THAT ARE ON DEVICES AND PAPERWORK AREN¿T CLEAR. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".