inforMED
MalfunctionFEM

WM-NP2 WORKSTATION SET 5 (EU)

Received Mar 10, 2025 · Event occurred Feb 17, 2025

Report 9611174-2025-00091 · MDR key 21564689

Device

Generic name

Wm-*p2 Series Of Endoscopy Workstations

Model number

K10021613

Product problems

  • Break
  • Break

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THIS REPORT WAS SENT IN ERROR, CHANGING THE WHEEL ON THE TOWER. WOULD NOT CAUSE OR CONTRIBUTE TO A DEATH OR A SERIOUS INJURY IF IT WERE TO RECUR.

Description of Event or Problem

NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

Description of Event or Problem

IT WAS REPORTED THE WORK STATION HAD A BROKEN WHEEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT. THE ISSUE OCCURRED DURING MAINTENANCE.

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.