PENTAX
Received Aug 11, 2021 · Event occurred Mar 29, 2021
Report 9610877-2021-10347 · MDR key 12305573
Device
Generic name
Endoscopic Video Imaging System/component
Manufacturer
Hoya Corporation Pentax Tokyo OfficeProduct problems
- Problem with Software Installation
- Problem with Software Installation
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
EVALUATION SUMMARY: BASED ON THE COMPLAINT DESCRIPTION, IT WAS OCCURRED DURING THE INSTALLATION OF PC AT THE HOSPITAL DUE TO THE SOFTWARE (B)(6) FAILURE. FROM THESE THINGS, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE SOFTWARE ERROR DURING THE INSTALLATION BUT NOT RELATED TO OUR PRODUCT. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.
Description of Event or Problem
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. OUR PENTAX FIELD SERVICE ENGINEER WAS ONSITE TO INSTALL SEVERAL NEW CAPTURE PCS, AND ONE OF THEM WOULD NOT BOOT UP TO WINDOWS AND FUNCTION PROPERLY. DESCRIPTION OF ANY ACTIONS TAKEN: HE TRIED RELOADING THE OPERATING SYSTEM (B)(6), BUT IT WAS STILL RUNNING EXTREMELY SLOW.