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Patient 1
THE HEAD MOTOR ASSEMBLY, AND THE BARIATRIC FOOT SECTION WERE RETURNED TO INVACARE. THE COMPLAINT WAS CONFIRMED DURING AN EVALUATION. IT WAS DETERMINED THAT THE 6-FUNCTION CONTROL BOX EMITTED SMOKE AND PRODUCED SPARKS WHEN THE HEAD DOWN FUNCTION OPERATED. BASED ON THE LOCATION OF WHERE THE SPARKS AND SMOKE WERE PRODUCED AND AFTER REVIEWING THE ENGINEERING DRAWING FOR THE 6-FUNCTION PCB, IT WAS DETERMINED THAT THE CAUSE THE OF THE FAILURE WAS A DIRECT SHORT TO CAPACITOR C1 OF THE 6-FUNCTION CONTROL BOX. IT WAS DETERMINED THAT THE FAILURE WAS CONTAINED TO THE 6-FUNCTION CONTROL BOX, AND THERE WAS NO MALFUNCTION OR DEFECT TO THE HEAD MOTOR. A REPLACEMENT BAR5490IVC FOOT SECTION, WAS SENT TO THE DEALER FOR SERVICING OF THE BED, THE CONTROL BOX DATE CODE, JULY 13, 2016, FALLS OUTSIDE THE SCOPE OF RECALLS Z-2399/2402-2016 AND Z-1182/1185-2017. HOWEVER, THE RETURNED CONTROL BOX WAS MANUFACTURED PRIOR TO A DESIGN CHANGE TO IMPLEMENT A NEW CAPACITOR, ICO-157061, WHICH WAS IMPLEMENTED ON FEBRUARY 10, 2017. SINCE LAUNCH OF THIS DESIGN CHANGE, THERE HAVE BEEN NO FAILURES. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.