FLOWTRON ACS900
Received Jun 30, 2026 · Event occurred Jun 11, 2026
Report 3005619970-2026-00020 · MDR key 25664255
Device
Product problems
- Melted
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CAUSE OF THE BURNT PLUG WAS INVESTIGATED BY THE MANUFACTURER, WHO CONDUCTED A SERIES TO FIND THE CAUSE OF THE ISSUE. THE TEST SHOWED THE PLUG'S INTERNAL WIRES HAD INTERMITTENT DISCONNECTION. THE MANUFACTURER SIMULATION SHOWED THAT WHEN THE POWER CORD IS USED OVER TIME, ESPECIALLY WHEN THE WIRE IS PULLED DIRECTLY TO UNPLUG IT, THE INNER WIRE MAY BECOME LOOSE, CAUSING THIS INTERMITTENT DISCONNECTION, AND FURTHER COULD PRODUCE ARCING. STRONG ARCING MAY PRODUCE SPARKS, AND THE INSULATING MATERIAL COULD BREAK, GENERATING THE GREEN SUBSTANCE (COPPER CHLORIDE), AND THE PLUG COULD MELT. TO SUM UP, ARJO DEVICE FAILED TO MEET ITS PERFORMANCE SPECIFICATION SINCE THE POWER CORD PLUG WAS MELTED. THERE WAS NO INDICATION THAT THE DEVICE WAS USED FOR THE PATIENT'S TREATMENT WHEN THE ISSUE OCCURRED. THE COMPLAINT WAS ASSESSED AS REPORTABLE DUE TO A BURNED DEVICE PLUG. THE DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS.
Description of Event or Problem
THE CUSTOMER REPORTED HAVING A FLOWTRON ACS900 WITH A DAMAGED SOCKET. THE PHOTOGRAPHIC EVIDENCE PROVIDED INDICATED A MELTED PLUG. NO PATIENT INVOLVEMENT WAS REPORTED, AND NO INJURY WAS CLAIMED.