AQUABPLUS 2000 B2 1500
Received Jan 12, 2026 · Event occurred Jan 7, 2026
Report 3010850471-2026-00001 · MDR key 24036398
Device
Product problems
- Sparking
Patient
NA · Unknown
- 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
THE BIOMEDICAL TECHNICIAN (BIOMED) CONTACTED FRESENIUS TECHNICAL SERVICES AFTER POWER LOSS OCCURRED AT THE USER FACILITY. THE POWER WAS RESTORED HOWEVER THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WOULD NOT POWER ON. UPON EVALUATION A SPARK FROM THE POWER SUPPLY WAS VISUALLY OBSERVED BY THE BIOMED. BLOWN FUSES WERE ALSO IDENTIFIED. THE FUSES AND POWER SUPPLY WERE REPLACED TO RESOLVE THE DAMAGE AND INITIAL POWER ISSUE. THE RO SYSTEM WAS RETURNED TO FULL SERVICE FOLLOWING REPAIR. NO PHOTOGRAPHS ARE AVAILABLE FOR REVIEW. NO PARTS ARE EXPECTED TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE MALFUNCTION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
PLANT INVESTIGATION: THE MANUFACTURER CONFIRMED THE REPORTED EVENT USING THE INFORMATION PROVIDED BY THE CUSTOMER. ACCORDING TO THE AVAILABLE INFORMATION, THERE WAS A LOSS OF THE MAINS POWER AT THE FACILITY. AFTER THE POWER WAS RESTORED, THE AQUABPLUS DEVICE WOULD NOT POWER BACK ON. A SPARK FROM THE 24VDC POWER SUPPLY WAS OBSERVED. THE 3.15A FUSES OF THE 24VDC POWER SUPPLY WERE FOUND BLOWN AND THE 24VDC POWER SUPPLY WAS FOUND DAMAGED. THE 24VDC POWER SUPPLY AND THE 3.15A FUSES WERE REPLACED TO SOLVE THE ISSUE. THE COMPLAINT INVESTIGATION DID NOT FIND OBJECTIVE EVIDENCE INDICATING A PRODUCT PROBLEM. THE INITIAL FAILURE CAUSE CAN BE ATTRIBUTED TO A POWER SURGE OF THE LOCAL MAINS POWER SUPPLY.
Description of Event or Problem
THE BIOMEDICAL TECHNICIAN (BIOMED) CONTACTED FRESENIUS TECHNICAL SERVICES AFTER POWER LOSS OCCURRED AT THE USER FACILITY. THE POWER WAS RESTORED HOWEVER THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WOULD NOT POWER ON. UPON EVALUATION A SPARK FROM THE POWER SUPPLY WAS VISUALLY OBSERVED BY THE BIOMED. BLOWN FUSES WERE ALSO IDENTIFIED. THE FUSES AND POWER SUPPLY WERE REPLACED TO RESOLVE THE DAMAGE AND INITIAL POWER ISSUE. THE RO SYSTEM WAS RETURNED TO FULL SERVICE FOLLOWING REPAIR. NO PHOTOGRAPHS ARE AVAILABLE FOR REVIEW. NO PARTS ARE EXPECTED TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE MALFUNCTION. NO ADDITIONAL INFORMATION WAS PROVIDED.