HF UNIT "ESG-400"
Received Jan 19, 2023 · Event occurred Dec 21, 2022
Report 9610773-2023-00281 · MDR key 16211025
Device
Product problems
- Device Alarm System
- Device Alarm System
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER'S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS 3003724334.
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS. DURING THE INSPECTION AT RC, IT'S FOUND THAT HIGH VOLTAGE POWER SUPPLY (HVPS) BOARD WAS FAULTY RESULTING IN E433 ERROR. FURTHERMORE, THE SBC IDENTIFIED DAMAGE TO AN UNSPECIFIED SCREW. SINCE STRONG VOLTAGE PEAKS MAY OCCUR AT THE OUTPUT TRANSFORMER OF THE GENERATOR BOARD, WHICH CAN DESTROY THE TRANSFORMER. A DEFECTIVE CABLE CONNECTION FOR THE OUTPUT SIGNAL BETWEEN THE GENERATOR BOARD AND THE RELAY BOARD (TEMPORARY OR PERMANENT ERROR). A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED SERIAL NUMBER WITHOUT SHOWING ANY NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUES. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.
Description of Event or Problem
IT WAS REPORTED TO OLYMPUS THAT A HF UNIT HAD A E433 ERROR. IT IS UNKNOWN WHEN THE REPORTED ISSUE WAS FOUND. IT WAS REPORTED THAT THE PATIENT WAS NOT UNDER SEDATION. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.