inforMED
MalfunctionLMD

OR1 NEO IP, ENH

Received Jul 22, 2022 · Event occurred Jun 24, 2022

Report 9610617-2022-00129 · MDR key 15085241

Device

Generic name

Neo Ip Controller

Model number

WUIS2546-01

Catalog number

WUIS2546-01

Product problems

  • No Display/Image
  • No Display/Image

Patient

Unknown

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

Narrative

Additional Manufacturer Narrative

OUR ONSITE TECHNICIAN WAS UNABLE TO REPRODUCE THE ISSUE, AND REPORTED THAT THE SITE DID HAVE A GROUNDING ISSUE ON A 120V RECEPTACLE IN THIS ROOM THAT HAS SINCE BEEN REPAIRED AFTER INCIDENT. CAUSE IS UNKNOWN AS WE WERE UNABLE TO REPLICATE THE ISSUE. SINCE THE ESU IS A ROLLING UNIT, THE SITE HAS BEEN INSTRUCTED TO ISOLATE THE MACHINE TO INCLUDE ALL CABLES AND UNIT FOR FURTHER EXTENSIVE TESTING IF THE PROBLEM OCCURS AGAIN.

Description of Event or Problem

CUSTOMER REPORTED THAT WHEN TRIGGERING THE ESU-ERBE VIO 300D, THE OLYMPUS CV-190 CAMERA IMAGE WOULD GO BLACK WHEN ROUTED TO ANY MONITOR/DISPLAY, INCLUDING VITALS. THE PATIENT NEEDED TO BE MOVED TO A DIFFERENT ROOM AND SURGEON WAS ABLE TO COMPLETE THE PROCEDURE; THERE WAS NO NEGATIVE PATIENT IMPACT.