AQUAC 20 AMP W/SOFTENER

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE AQUAC REVERSE OSMOSIS (RO) SYSTEM HAS NO POWER. UPON EVALUATION, A BURNT CAPACITOR WAS IDENTIFIED ON THE POWER SUPPLY BOARD. THE PART NUMBER FOR THE POWER SUPPLY WAS REQUESTED. P/N F50007278 WAS PROVIDED. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE BIOMED. THE POWER SUPPLY BOARD WAS REPLACED TO RESOLVE THE REPORTED POWER ISSUE AND IDENTIFIED THERMAL DECOMPOSITION. THE AQUAC COMPLETED RINSE AND HEAT CYCLES WITHOUT ISSUE AND THE SYSTEM WAS RETURNED TO SERVICE. NO OTHER PARTS SUSTAINED DAMAGE NOR REQUIRED REPAIR. THE BIOMED RE-CONFIRMED THAT THERE WAS NO REPORTED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THE BIOMED STATED THE FUSES WERE CHECKED FOR CONTINUITY AND NO ISSUES WERE IDENTIFIED. THERE WERE NO LOCAL POWER GRID ISSUES, POWER SURGES, OR ELECTRICAL STORMS ON OR AROUND THE REPORTED EVENT DATE. THE POWER SUPPLY BOARD WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE.

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE DEFECTIVE 24VDC POWER SUPPLY UNIT WAS DISCARDED. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER, THE REPORTED EVENT WAS CONFIRMED BY THE MANUFACTURER USING THE PHOTOGRAPH PROVIDED UPON INITIAL REPORTING. THE ISSUE WAS LIKELY CAUSED BY A FAULTY COMPONENT IN THE 24VDC POWER SUPPLY UNIT AND THE POWER SUPPLY UNIT WAS NO LONGER WORKING, AS THE MOTHERBOARD CANNOT START AND THE AQUAC UNO H CANNOT WORK WITHOUT THE 24V SUPPLY VOLTAGE. THE POWER SUPPLY UNIT IS A SUPPLIER PART, AND A SUPPLIER NON-CONFORMITY REPORT CANNOT BE INITIATED WITHOUT AVAILABILITY OF THE COMPLAINT SAMPLE. THEREFORE, THE INITIAL FAILURE CAUSE FOR THE FAULTY COMPONENT CANNOT BE DETERMINED. ACCORDING TO THE PROVIDED INFORMATION, THE ISSUE WAS SOLVED BY REPLACING THE DAMAGED 24VDC POWER SUPPLY UNIT.

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 TECHNICAL SERVICES THAT THE AQUAC REVERSE OSMOSIS (RO) SYSTEM HAS NO POWER. UPON EVALUATION, A BURNT CAPACITOR WAS IDENTIFIED ON THE POWER SUPPLY BOARD. THE PART NUMBER FOR THE POWER SUPPLY WAS REQUESTED. P/N F50007278 WAS PROVIDED. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE BIOMED. THE POWER SUPPLY BOARD WAS REPLACED TO RESOLVE THE REPORTED POWER ISSUE AND IDENTIFIED THERMAL DECOMPOSITION. THE AQUAC COMPLETED RINSE AND HEAT CYCLES WITHOUT ISSUE AND THE SYSTEM WAS RETURNED TO SERVICE. NO OTHER PARTS SUSTAINED DAMAGE NOR REQUIRED REPAIR. THE BIOMED RE-CONFIRMED THAT THERE WAS NO REPORTED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THE BIOMED STATED THE FUSES WERE CHECKED FOR CONTINUITY AND NO ISSUES WERE IDENTIFIED. THERE WERE NO LOCAL POWER GRID ISSUES, POWER SURGES, OR ELECTRICAL STORMS ON OR AROUND THE REPORTED EVENT DATE. THE POWER SUPPLY BOARD WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE.