AQUAA 1800H
Received Jun 18, 2024 · Event occurred Jun 5, 2024
Report 3010850471-2024-00052 · MDR key 19563705
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 USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT ERROR "W¿02¿02¿17 WARNING: STAGE 2, CONC. PRESSURE BELOW ALARM LIMIT" WAS RECEIVED IN SUPPLY MODE. THERMAL DECOMPOSITION WAS IDENTIFIED UPON EVALUATION. THE OUTLET SOCKET OF THE POWER DISTRIBUTION CENTER WAS CHARRED AS WAS THE POWER PLUG THAT FEEDS THE RO SYSTEM. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. A LIGHT BURNING SMELL WAS NOTED, BUT NO SMOKE, SPARK, FLAME, OR ARCING WAS OBSERVED. NO BLOWN FUSES WERE IDENTIFIED. THERE WERE NO LOCAL POWER GRID ISSUES OR ELECTRICAL STORMS IN THE AREA ON OR AROUND THE REPORTED EVENT DATE. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. THE PLUG AND SOCKET WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM HAS BEEN RETURNED TO SERVICE. 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.