WM-NP2 WORKSTATION SET 4 (US)

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

THE SUBJECT DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED FOR EVALUATION. THE ISSUE WAS RESOLVED WITH TECHNICAL SUPPORT VIA TELEPHONE, AS THE CUSTOMER REQUESTED TO PURCHASE A REPLACEMENT CASTER/PARTS TO REMOVE AND REPLACE THE DAMAGED CASTER. THE INVESTIGATION IS ONGOING; THEREFORE, THE ROOT CAUSE OF THE REPORTED MALFUNCTION CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

Description of Event or Problem

THE USER FACILITY REPORTED, DURING AN UNSPECIFIED EVENT THE BOLT THAT HOLD THE NON-BRAKE CASTOR ON THE WORKSTATION BROKE IN HALF. THERE WAS NO REPORT OF PATIENT OR USER INJURY OR HARM.