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Patient 1
VISUAL FINDINGS REVEALED THAT THE DEVICE BATTERY COMPARTMENT HAS SIGNS OF PREVIOUS BATTERY CORROSION SUCH AS WHITE POWDER RESIDUE ON BATTERY FLAT CONTACTS, BATTERY SPRINGS, COMPARTMENT SIDE WALL, THE BACK OF THE BATTERY DOOR, AND RED RIBBON. EVALUATION FOUND WHEN THE UNIT IS SET TO VOICE ONLY AND VOICE & TONE MODES, THE PRE-RECORDED VOICE MESSAGE WILL NOT PLAY ? ONLY CLICKING SOUNDS CAN BE HEARD WHEN WEIGHT IS OFF THE SENSOR PAD DUE TO A DEFECTIVE VOICE CHIP. DUE TO THE AGE OF THE DEVICE IT IS LIKELY THAT WEAR AND TEAR MAY HAVE CONTRIBUTED TO THE MALFUNCTION. AT THIS TIME, THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT AND THE INSTRUCTIONS FOR USE WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNING FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANT. MANUFACTURER REFERENCE FILE#: (B)(4).