AQUAC 20 AMP W/SOFTENER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H3 PLANT INVESTIGATION: THE REPORTED ISSUE HAS BEEN CONFIRMED BY THE MANUFACTURER BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER. THE REPORTED EVENT WAS DISCOVERED WHILE TROUBLESHOOTING A TRIPPED BREAKER WITHIN THE MACHINE. THIS IS LIKELY A KNOWN ISSUE THAT CAN BE ATTRIBUTED TO A DESIGN FLAW OF THE POWER SUPPLY BOARD COMBINED WITH THE OCCURRENCE OF A LOCAL POWER SURGE. THE POWER SUPPLY UNIT MANUFACTURER IMPLEMENTED CORRECTIVE ACTIONS AND AN INTRODUCED AN IMPROVED DESIGN FOR THE POWER SUPPLY UNIT IN MAY 2022 IN SERIES PRODUCTION. THE CONCERNED FAULTY POWER SUPPLY UNIT WAS MANUFACTURED BEFORE THE DESIGN IMPROVEMENT. THE REVIEW OF THE REPAIR HISTORY REVEALS NO PREVIOUS COMPLAINT. IT IS THEREFORE ASSUMED THAT THE ORIGINAL POWER SUPPLY UNIT WAS INSTALLED AT THE TIME OF THE EVENT. ACCORDING TO THE INTAKE INFORMATION, THE REPORTED EVENT WAS SOLVED BY REPLACING THE DEFECTIVE POWER SUPPLY UNIT.

Description of Event or Problem

A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE WHEN A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT THE AQUAC REVERSE OSMOSIS (RO) SYSTEM HAD NO POWER. THE FST INDICATED IN THE COMPLETED SERVICE CONFIRMATION THAT BURNED/CHARRED WIRING WAS IDENTIFIED WITHIN THE RO SYSTEM DURING THE REPAIR. THE FST CONFIRMED THE REPORTED EVENT DURING FOLLOW-UP AND PROVIDED ADDITIONAL INFORMATION. THE FST STATED THERE WAS MILD DISCOLORATION IDENTIFIED ON THE BACK OF THE POWER CONTROL BOARD THAT COULD HAVE BEEN CAUSED FROM HEAT EXPOSURE. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THERE WERE NO BLOWN FUSES OR TRIPPED SWITCHES. THERE WERE NO REPORTED LOCAL POWER GRID ISSUES OR ELECTRICAL STORMS. THE FST NOTED THAT THE CUSTOMER HAD REPORTED A TRIPPED BREAKER BEFORE THE REPORTED ISSUE WAS IDENTIFIED. THE FST CONFIRMED THAT THE POWER SUPPLY BOARD WAS REPLACED TO RESOLVE THE REPORTED ISSUE. NO OTHER DAMAGE WAS NOTED AND NO OTHER PARTS REQUIRED REPLACEMENT. THE RO SYSTEM WAS RELEASED TO THE CUSTOMER TO RETURN TO SERVICE FOLLOWING REPAIR. THE SAMPLE WAS RETURNED TO THE MANUFACTURER VIA RETURN GOODS AUTHORIZATION (RGA) NUMBER FOR PHYSICAL EVALUATION. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION.

Additional Manufacturer Narrative

CORRECTION: H6 (INVESTIGATION CONCLUSIONS).

Description of Event or Problem

A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE WHEN A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT THE AQUAC REVERSE OSMOSIS (RO) SYSTEM HAD NO POWER. THE FST INDICATED IN THE COMPLETED SERVICE CONFIRMATION THAT BURNED/CHARRED WIRING WAS IDENTIFIED WITHIN THE RO SYSTEM DURING THE REPAIR. THE FST CONFIRMED THE REPORTED EVENT DURING FOLLOW-UP AND PROVIDED ADDITIONAL INFORMATION. THE FST STATED THERE WAS MILD DISCOLORATION IDENTIFIED ON THE BACK OF THE POWER CONTROL BOARD THAT COULD HAVE BEEN CAUSED FROM HEAT EXPOSURE. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THERE WERE NO BLOWN FUSES OR TRIPPED SWITCHES. THERE WERE NO REPORTED LOCAL POWER GRID ISSUES OR ELECTRICAL STORMS. THE FST NOTED THAT THE CUSTOMER HAD REPORTED A TRIPPED BREAKER BEFORE THE REPORTED ISSUE WAS IDENTIFIED. THE FST CONFIRMED THAT THE POWER SUPPLY BOARD WAS REPLACED TO RESOLVE THE REPORTED ISSUE. NO OTHER DAMAGE WAS NOTED AND NO OTHER PARTS REQUIRED REPLACEMENT. THE RO SYSTEM WAS RELEASED TO THE CUSTOMER TO RETURN TO SERVICE FOLLOWING REPAIR. THE SAMPLE WAS RETURNED TO THE MANUFACTURER VIA RETURN GOODS AUTHORIZATION (RGA) NUMBER FOR PHYSICAL EVALUATION. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION.

Description of Event or Problem

A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE WHEN A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT THE AQUAC REVERSE OSMOSIS (RO) SYSTEM HAD NO POWER. THE FST INDICATED IN THE COMPLETED SERVICE CONFIRMATION THAT BURNED/CHARRED WIRING WAS IDENTIFIED WITHIN THE RO SYSTEM DURING THE REPAIR. THE FST CONFIRMED THE REPORTED EVENT DURING FOLLOW-UP AND PROVIDED ADDITIONAL INFORMATION. THE FST STATED THERE WAS MILD DISCOLORATION IDENTIFIED ON THE BACK OF THE POWER CONTROL BOARD THAT COULD HAVE BEEN CAUSED FROM HEAT EXPOSURE. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THERE WERE NO BLOWN FUSES OR TRIPPED SWITCHES. THERE WERE NO REPORTED LOCAL POWER GRID ISSUES OR ELECTRICAL STORMS. THE FST NOTED THAT THE CUSTOMER HAD REPORTED A TRIPPED BREAKER BEFORE THE REPORTED ISSUE WAS IDENTIFIED. THE FST CONFIRMED THAT THE POWER SUPPLY BOARD WAS REPLACED TO RESOLVE THE REPORTED ISSUE. NO OTHER DAMAGE WAS NOTED AND NO OTHER PARTS REQUIRED REPLACEMENT. THE RO SYSTEM WAS RELEASED TO THE CUSTOMER TO RETURN TO SERVICE FOLLOWING REPAIR. THE SAMPLE WAS RETURNED TO THE MANUFACTURER VIA RETURN GOODS AUTHORIZATION (RGA) NUMBER FOR PHYSICAL EVALUATION. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION.

Additional Manufacturer Narrative

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