AQUAC UNO H (120V, 60HZ, 1700VA)
Received Sep 15, 2023 · Event occurred Sep 5, 2023
Report 3010850471-2023-00063 · MDR key 17756424
Device
Product problems
- Smoking
- Smoking
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT SMOKE WAS OBSERVED COMING FROM THE AQUA C UNO H REVERSE OSMOSIS (RO) SYSTEM. THERE WERE NO FURTHER INDICATIONS OF THERMAL DAMAGE. THE COVER WAS LIFTED AND NO BURNT OR CHARRED COMPONENTS WERE IDENTIFIED. THERE WAS NO PATIENT INVOLVEMENT REGARDING THE REPORTED ISSUE. THE BIOMED INITIALLY CONTACTED FRESENIUS TECHNICAL SERVICES AFTER THE RO SYSTEM DISPLAYED THE ERROR MESSAGE "FILL LEVEL CANNOT BE LOWERED" DURING THE T1 TEST. ERROR CODE F-02-60-06 WAS RECEIVED. THE CUSTOMER STRAIGHTENED THE DRAIN LINES WHICH CLEARED THE ERROR MESSAGE. THE CUSTOMER RAN A DEVICE TEST TO IDENTIFY ANY FAULTY COMPONENTS. NO ADDITIONAL ISSUES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.
Additional Manufacturer Narrative
CORRECTION: THE INITIAL REPORTER OF THIS EVENT PROVIDED ADDITIONAL INFORMATION DURING FOLLOW-UP CLARIFYING THAT THERE WAS NO SMOKE NOR VISUAL INDICATION OF THERMAL DAMAGE IDENTIFIED WITHIN THE SYSTEM. IT HAS BEEN DETERMINED THAT THE EVENT REPORTED ON 3010850471-2023-000630 WAS NOT A REPORTABLE EVENT RELATED TO FRESENIUS MEDICAL CARE (FMC) PRODUCTS. THERE WILL BE NO FURTHER UPDATES ON 3010850471-2023-00063.
Description of Event or Problem
A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT SMOKE WAS OBSERVED COMING FROM THE AQUA C UNO H REVERSE OSMOSIS (RO) SYSTEM. THERE WERE NO FURTHER INDICATIONS OF THERMAL DAMAGE. THE COVER WAS LIFTED AND NO BURNT OR CHARRED COMPONENTS WERE IDENTIFIED. THERE WAS NO PATIENT INVOLVEMENT REGARDING THE REPORTED ISSUE. THE BIOMED INITIALLY CONTACTED FRESENIUS TECHNICAL SERVICES AFTER THE RO SYSTEM DISPLAYED THE ERROR MESSAGE "FILL LEVEL CANNOT BE LOWERED" DURING THE T1 TEST. ERROR CODE F-02-60-06 WAS RECEIVED. THE CUSTOMER STRAIGHTENED THE DRAIN LINES WHICH CLEARED THE ERROR MESSAGE. THE CUSTOMER RAN A DEVICE TEST TO IDENTIFY ANY FAULTY COMPONENTS. NO ADDITIONAL ISSUES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED. NO PARTS WERE 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.