AQUAC 20 AMP W/SOFTENER

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE DEFECTIVE KEYPAD CONNECTOR WAS RETURNED FOR PHYSICAL EVALUATION. A SOLDER JOINT WITH CORROSION DAMAGE WAS IDENTIFIED DURING EVALUATION. NO THERMAL DAMAGE AS REPORTED BY LOCAL SERVICE WAS IDENTIFIED. THE CORROSION WAS MOST LIKELY CAUSED BY PRODUCTION FAILURE OF THE KEYPAD CONNECTOR, HOWEVER THE KEYPAD CONNECTOR REMAINS FUNCTIONAL. THE REPORTED THERMAL DECOMPOSITION CANNOT BE CONFIRMED BASED ON THE COMPLAINT INVESTIGATION. REPLACING THE KEYPAD CONNECTOR THE TOUCHPAD FAILURE AND IDENTIFIED CORROSION. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED. THE DEVICE WAS FOUND TO BE CONFORMING TO PRODUCT SPECIFICATIONS AND HAS BEEN RELEASED WITHOUT ANY DISCREPANCIES. NO MALFUNCTION AND NO SOLDER JOINT CORROSION OF THE KEYPAD CONNECTOR WAS DETERMINED DURING THE FINAL TEST PROCEDURE.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS THAT THERMAL DECOMPOSITION WAS IDENTIFIED ON THE CONNECTOR COVER ASSEMBLY OF THE KEYPAD OF THE AQUAC MACHINE. THE BIOMED STATED THAT THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE REPAIR. THE AQUAC MACHINE WAS INITIALLY EVALUATED AFTER THE TOUCH PAD COULD NOT BE USED TO SCROLL UP AND DOWN. THE KEYPAD WAS INITIALLY REPLACED HOWEVER THE ISSUE PERSISTED. PLUGGING IN A KNOWN GOOD KEYPAD ISOLATED THE ISSUE TO THE CONNECTOR COVER ASSEMBLY. THE CONNECTOR COVER ASSEMBLY WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. NO BLOWN FUSES WERE IDENTIFIED. THERE WERE NO POWER ISSUES AT THE FACILITY ON OR AROUND THE REPORTED EVENT DATE. IT WAS CONFIRMED THE AQUAC MACHINE IS PLUGGED INTO ONLY HOSPITAL-GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLETS. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. THE BIOMED STATED THAT FTP FILES ARE NOT AVAILABLE TO BE OBTAINED FOR REVIEW AS AN SD CARD WAS NOT INSERTED AT THE TIME OF THE REPORTED ISSUE. THE PART WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS THAT THERMAL DECOMPOSITION WAS IDENTIFIED ON THE CONNECTOR COVER ASSEMBLY OF THE KEYPAD OF THE AQUAC MACHINE. THE BIOMED STATED THAT THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE REPAIR. THE AQUAC MACHINE WAS INITIALLY EVALUATED AFTER THE TOUCH PAD COULD NOT BE USED TO SCROLL UP AND DOWN. THE KEYPAD WAS INITIALLY REPLACED HOWEVER THE ISSUE PERSISTED. PLUGGING IN A KNOWN GOOD KEYPAD ISOLATED THE ISSUE TO THE CONNECTOR COVER ASSEMBLY. THE CONNECTOR COVER ASSEMBLY WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. NO BLOWN FUSES WERE IDENTIFIED. THERE WERE NO POWER ISSUES AT THE FACILITY ON OR AROUND THE REPORTED EVENT DATE. IT WAS CONFIRMED THE AQUAC MACHINE IS PLUGGED INTO ONLY HOSPITAL-GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLETS. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. THE BIOMED STATED THAT FTP FILES ARE NOT AVAILABLE TO BE OBTAINED FOR REVIEW AS AN SD CARD WAS NOT INSERTED AT THE TIME OF THE REPORTED ISSUE. THE PART WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.