AQUAC 20 AMP W/SOFTENER
Received Jun 5, 2024 · Event occurred May 8, 2024
Report 3010850471-2024-00047 · MDR key 19470516
Device
Product problems
- Thermal Decomposition of Device
- Thermal Decomposition of Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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 CLINIC MANAGER (CM) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE AQUAC REVERSE OSMOSIS (RO) SYSTEM WOULD NOT POWER UP. THE CM ATTEMPTED TO USE ANOTHER VERIFIED POWER SOURCE WHICH DID NOT RESOLVE THE ISSUE. THE CM ALSO STATED THAT ON THE PRIOR DAY THE SCREEN ON THE RO SYSTEM WAS DARK BUT WOULD LIGHT UP WHEN PRESSING A KEY. ONSITE SERVICE WAS REQUESTED. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) CAME ONSITE TO EVALUATION THE SYSTEM. THE CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE THE POWER SUPPLY. THERMAL DECOMPOSITION WAS ALSO NOTED ON THE PART. THE POWER SUPPLY WAS REPLACED TO RESOLVE THE REPORTED ISSUE. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED. THERE WAS NO REPORTED HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. NO PARTS WERE REPORTED TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.
Description of Event or Problem
A USER FACILITY CLINIC MANAGER (CM) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE AQUAC REVERSE OSMOSIS (RO) SYSTEM WOULD NOT POWER UP. THE CM ATTEMPTED TO USE ANOTHER VERIFIED POWER SOURCE WHICH DID NOT RESOLVE THE ISSUE. THE CM ALSO STATED THAT ON THE PRIOR DAY THE SCREEN ON THE RO SYSTEM WAS DARK BUT WOULD LIGHT UP WHEN PRESSING A KEY. ONSITE SERVICE WAS REQUESTED. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) CAME ONSITE TO EVALUATION THE SYSTEM. THE CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE THE POWER SUPPLY. THERMAL DECOMPOSITION WAS ALSO NOTED ON THE PART. THE POWER SUPPLY WAS REPLACED TO RESOLVE THE REPORTED ISSUE. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED. THERE WAS NO REPORTED HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. NO PARTS WERE REPORTED TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.
Additional Manufacturer Narrative
PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER A PHOTOGRAPH WAS PROVIDED AND USED ALONG WITH THE CASE DETAILS TO CONFIRM THE REPORTED ISSUE. THE MOST LIKELY FAILURE CAUSE IS KNOWN AND CAN BE ATTRIBUTED TO A DESIGN FLAW OF THE 24 VDC POWER SUPPLY UNIT IN COMBINATION WITH A LOCAL POWER SURGE. THE CONCERNED 24 VDC POWER SUPPLY UNIT IS A SUPPLIER PART. THE POWER SUPPLY UNIT MANUFACTURER ANNOUNCED CORRECTIVE ACTIONS FOR THIS PART. DESIGN IMPROVEMENT WAS MADE AND IMPLEMENTED IN THE POWER SUPPLY UNIT. ACCORDING TO THE AVAILABLE INFORMATION, THE 24 VDC POWER SUPPLY UNIT WAS REPLACED TO SOLVE THE ISSUE.