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Patient 1
EVALUATION RESULTS: THE DEVICE WAS RETURNED AND ANALYZED. THE DEVICE WAS RECEIVED IN WITH NO PHYSICAL DAMAGES NOTED AND POWERED ON WITH NO ISSUE. HOWEVER FUNCTIONAL TESTING SHOWED THE DEVICE DID NOT SOUND WHEN IN USE WITH THE PULL MAGNET. UPON OPENING THE DEVICE, THE CAUSE FOR THE FAILURE WAS A FAULTY SPEAKER, WHERE THE SPEAKER IMPEDANCE WAS OUT OF RANGE. THIS LOSS OF FUNCTIONALITY WOULD RESULT IN THE ALARM?S FAILURE TO ALERT THE CAREGIVER OF A PATIENT EXIT AND COULD CONTRIBUTE TO A PATIENT INCIDENT. BEING THAT THE DEVICE HAD BEEN IN USE FOR OVER A YEAR, IT IS LIKELY NORMAL WEAR AND TEAR THAT CONTRIBUTED TO THE REPORTED ISSUE. AT THIS TIME, THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT AND THE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNING FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. THE IFU STATES "TO REDUCE THE RISK OF SERIOUS INJURY OR DEATH, TEST THE ALARM AND SENSOR FOR PROPER OPERATION PRIOR TO PUTTING IN SERVICE WITH A PATIENT, AND EACH TIME BEFORE LEAVING THE PATIENT UNATTENDED. IF THE ALARM AND/OR SENSOR DO NOT FUNCTION PROPERLY, REMOVE THE ALARM AND SENSOR FROM SERVICE AND REPLACE THEM WITH A PROPERLY FUNCTIONING ALARM AND/OR SENSOR. DO NOT USE THE ALARM, SENSOR OR MAGNET IF IT DOES NOT ACTIVATE EACH TIME WEIGHT IS REMOVED FROM THE SENSOR, THE CHAIR BELT SENSOR IS UNFASTENED, OR MAGNET IS REMOVED FROM FACE PLATE." 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).