WM-NP2 WORKSTATION SET 1 (EU)
Received Apr 22, 2025 · Event occurred Apr 1, 2025
Report 9611174-2025-00133 · MDR key 21886784
Device
Generic name
Work Station
Manufacturer
Keymed (medical And Industrial Equipment) Ltd.Model number
K10021765Product problems
- Break
- Naturally Worn
- Break
- Naturally Worn
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
Description of Event or Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE WORK STATION EXHIBITED 4 DAMAGED CARRIAGE WHEELS. THERE WAS NO PATIENT INVOLVEMENT.