inforMED
MalfunctionOCS

PENTAX

Received Aug 11, 2021 · Event occurred Mar 29, 2021

Report 9610877-2021-10346 · MDR key 12305577

Device

Generic name

Endoscopic Video Imaging System/component

Product problems

  • Intermittent Communication Failure
  • Intermittent Communication Failure

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, WE FOUND THAT THERE WERE SEVERAL PRODUCTS IN USE, WHICH WERE THE PC, THE DELL MONITOR, AND THE CONNECTION CABLES. FROM THESE THINGS, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE CONNECTION PROBLEM BETWEEN THE DELL MONITOR AND THE PC SUCH AS THE CABLE DISCONNECTION WHICH IS 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 THE DELL MONITORS THAT CAME WITH THEM WOULD NOT DISPLAY A PICTURE. DESCRIPTION OF ANY ACTIONS TAKEN: HE TRIED MULTIPLE CABLES AND CONNECTIONS AND EVEN DIFFERENT COMPUTERS, BUT IT WOULD NOT DISPLAY AN IMAGE.