OR1 NEO IP, BAS
Received Nov 3, 2023 · Event occurred Jul 22, 2021
Report 9610617-2023-00363 · MDR key 18070010
Device
Generic name
Medical Image Communications Device
Manufacturer
Karl Storz Se & Co. KgModel number
WUIS2545-01Catalog number
WUIS2545-01
Product problems
- Erratic or Intermittent Display
- Fire
- Erratic or Intermittent Display
- Fire
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A CASE, ONE OF THE TWO 32" MONITORS WAS FLICKERING. AND AFTER FURTHER INVESTIGATION BY OUR ON-SITE TECHNICIAN, WE FOUND OUT THAT THE POWER SUPPLY WENT ON FIRE AND BURNED THE CABLES. NO PATIENT OR USER INJURY WAS REPORTED.
Additional Manufacturer Narrative
THE PREVIOUS REPORTABILITY DECISION FOR THIS EVENT WAS REVERSED BASED ON A RETROSPECTIVE REVIEW. THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT RETURNED FOR INVESTIGATION. DEVICE WAS SERVICED BY ON-SITE TECHNICIAN AT CUSTOMER LOCATION. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).