AQUAC 20 AMP W/SOFTENER
Received Feb 12, 2024 · Event occurred Jan 26, 2024
Report 3010850471-2024-00011 · MDR key 18685767
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
Description of Event or Problem
A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE BY A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) AFTER A BURNT AND DEFECTIVE PCB BOARD WAS IDENTIFIED WITHIN THE AQUAC REVERSE OSMOSIS (RO) SYSTEM. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE REPAIR. THE RO SYSTEM HAD NO POWER WHEN PLUGGED INTO THE POWER OUTLET. THE BIOMED STATED THAT A BURNING SMELL WAS NOTED. THE FST REPLACED THE POWER SUPPLY TO RESOLVE THE REPORTED ISSUE. THE RO MACHINE POWERED ON AND COMPLETED A RINSE CYCLE WITHOUT ISSUE. THE RO MACHINE PASSED THE SELF-DEVICE TEST AND THE T1 TEST PASSED. AN ELECTRICAL LEAKAGE TEST WAS PERFORMED ALL WITH EXPECTED VALUES: OHMS 0.056, NOMINAL VOLTAGE OF POWER SUPPLY 122.0V, DEVICE LEAKAGE CURRENT POWER SUPPLY POLARITY 1 65UA, WITH LINE VOLTAGE 122.0V, STANDARDIZED TO NOMINAL VOLTAGE 65.0UA, DEVICE LEAKAGE CURRENT POWER SUPPLY POLARITY 2 126UA, WITH LINE VOLTAGE 122.0V, STANDARDIZED TO NOMINAL VOLTAGE 126UA. SYSTEM FILES WERE CAPTURED AND UPLOADED. THE RO SYSTEM WAS RETURNED TO THE CUSTOMER TO BE PLACED INTO SERVICE. THE BIOMED CONFIRMED DURING FOLLOW-UP THAT THE RO SYSTEM WAS RETURNED TO SERVICE.
Additional Manufacturer Narrative
PLANT INVESTIGATION: NO SAMPLES WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER THE MANUFACTURER CONFIRMED THE REPORTED EVENT BASED ON THE PROVIDED INFORMATION AND SAMPLE PHOTOGRAPHS. ELECTRICAL COMPONENTS AT THE POWER SUPPLY UNIT WERE OVERHEATED CAUSING THE REPORTED THERMAL DAMAGE. THE POWER SUPPLY UNIT IS NOT ROBUST ENOUGH AGAINST TEMPORARY POWER SURGES AND CAN MOST LIKELY ASSIGNED TO A DESIGN FLAW OF THE POWER SUPPLY UNIT COMBINED WITH A LOCAL OCCURRED POWER SURGE. THIS IS A KNOWN ISSUE. THE ALLEGED DEFECTIVE POWER SUPPLY UNIT IS A SUPPLIER PART. THE POWER SUPPLY UNIT MANUFACTURER ANNOUNCED CORRECTIVE ACTIONS AND A DESIGN IMPROVEMENT WAS IMPLEMENTED TO THE POWER SUPPLY UNIT. THE DEVICE WAS BUILT BEFORE THE IMPROVEMENT OF THE DESIGN. IN THIS INSTANCE THE POWER SUPPLY UNIT WAS REPLACED TO RESOLVE THE REPORTED ISSUE.
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 FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE BY A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) AFTER A BURNT AND DEFECTIVE PCB BOARD WAS IDENTIFIED WITHIN THE AQUAC REVERSE OSMOSIS (RO) SYSTEM. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE REPAIR. THE RO SYSTEM HAD NO POWER WHEN PLUGGED INTO THE POWER OUTLET. THE BIOMED STATED THAT A BURNING SMELL WAS NOTED. THE FST REPLACED THE POWER SUPPLY TO RESOLVE THE REPORTED ISSUE. THE RO MACHINE POWERED ON AND COMPLETED A RINSE CYCLE WITHOUT ISSUE. THE RO MACHINE PASSED THE SELF-DEVICE TEST AND THE T1 TEST PASSED. AN ELECTRICAL LEAKAGE TEST WAS PERFORMED ALL WITH EXPECTED VALUES: OHMS 0.056, NOMINAL VOLTAGE OF POWER SUPPLY 122.0V, DEVICE LEAKAGE CURRENT POWER SUPPLY POLARITY 1 65UA, WITH LINE VOLTAGE 122.0V, STANDARDIZED TO NOMINAL VOLTAGE 65.0UA, DEVICE LEAKAGE CURRENT POWER SUPPLY POLARITY 2 126UA, WITH LINE VOLTAGE 122.0V, STANDARDIZED TO NOMINAL VOLTAGE 126UA. SYSTEM FILES WERE CAPTURED AND UPLOADED. THE RO SYSTEM WAS RETURNED TO THE CUSTOMER TO BE PLACED INTO SERVICE. THE BIOMED CONFIRMED DURING FOLLOW-UP THAT THE RO SYSTEM WAS RETURNED TO SERVICE.