ORG-9110A
Received Apr 11, 2026 · Event occurred Apr 1, 2026
Report 8030229-2026-06451 · MDR key 24848867
Device
Generic name
Multiple Patient Receiver
Manufacturer
Nihon Kohden CorporationModel number
ORG-9110ACatalog number
ORG-9110A
Lot number
NA
Product problems
- Communication or Transmission Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) ORG WAS DROPPING OFF THE NETWORK RANDOMLY. HE SAID IT WILL NOT SHOW ON HOST TABLE AT ALL EVEN THOUGH ORG DOES NOT HAVE ERROR LIGHTS. THEY CONFIRMED IT IS NOT A NETWORK CABLE OR SWITCH ISSUE ALREADY BY TESTING DIFFERENT PORTS AND CABLES. THIS WOULD AFFECT THE ZM TRANSMITTERS. NO PATIENT HARM WAS REPORTED. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) ORG WAS DROPPING OFF THE NETWORK RANDOMLY. HE SAID IT WILL NOT SHOW ON HOST TABLE AT ALL EVEN THOUGH ORG DOES NOT HAVE ERROR LIGHTS. THEY CONFIRMED IT IS NOT A NETWORK CABLE OR SWITCH ISSUE ALREADY BY TESTING DIFFERENT PORTS AND CABLES. THIS WOULD AFFECT THE ZM TRANSMITTERS. NO PATIENT HARM WAS REPORTED.