D
Patient 1
WE ARE A DENTAL OFFICE AND PURCHASED A TRAVERSE DENTAL CHAIR FROM ENGLE DENTAL SYSTEMS. THIS CHAIR IS THE ONLY TYPE OF CHAIR MANUFACTURED THAT TRAVERSES INTO A LAYING DOWN POSITION WHILE ALSO MOVING FORWARD. THE CHAIR HAS A METAL MOUNT FOR OTHER EQUIPMENT THAT IS POSITIONED IN SUCH A WAY THAT IT CAN (AND HAS) CLOSED ON AN AREA WHILE IN MOTION THAT COULD SERIOUSLY INJURE A PT'S APPENDAGE. THE MFR WAS NOTIFIED BUT FAILED TO REPORT OR RESOLVE THE ISSUE BECAUSE WE ARE THE ONLY OFFICE THAT BROUGHT UP THE ISSUE. THEY ACKNOWLEDGED THE ISSUE BUT HAVE NOT REPORTED THE DESIGN FLAW, ARE IGNORING THE SAFETY CONCERN, AND HAVE NOT ALTERED THE DESIGN. THEY ARE STILL SELLING IT KNOWING THERE IS A DEFECT AND RISK TO PUBLIC SAFETY. THE MFR RECENTLY SENT A LETTER STATING THAT THEY DETERMINED THAT THE INJURY COULD OCCUR OUTSIDE OF THE NORMAL OPERATION OF THE CHAIR WHICH IS NOT ACCURATE, THE CHAIR WAS DESIGNED IN A WAY TO ALLOW THE POTENTIAL FOR INJURY WITH THE PROPER AND INTENDED USAGE OF THE CHAIR. (B)(4); DENTAL MFR IS AWARE THAT THERE IS A DEFECT. DOCUMENT NUMBER: (B)(4).