ORG-9110A
Received Jun 22, 2026 · Event occurred Jun 1, 2026
Report 8030229-2026-06686 · MDR key 25586002
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 THEY HAVE THIS MULTIPLE PATIENT RECEIVER (ORG) GOING INTO COMM LOSS FOR ABOUT 30 SECONDS AND THEN COMES BACK. CUSTOMER STATES THAT THIS SEEMS RANDOM, APPROXIMATELY EVERY 30MIN OR SO. THIS IS AFFECTING ONLY ONE ORG, BED-ID'S TELE20- TELE26. ALL 7 BEDS ARE GOING INTO COMM LOSS AT THE SAME TIME (THIS ORG IS ONLY SETUP FOR 7 BEDS, THERE IS A FREE, UNUSED CHANNEL THAT IS NOT BEING MONITORED). 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 THEY HAVE THIS MULTIPLE PATIENT RECEIVER (ORG) GOING INTO COMM LOSS FOR ABOUT 30 SECONDS AND THEN COMES BACK. CUSTOMER STATES THAT THIS SEEMS RANDOM, APPROXIMATELY EVERY 30MIN OR SO. THIS IS AFFECTING ONLY ONE ORG, BED-ID'S TELE20- TELE26. ALL 7 BEDS ARE GOING INTO COMM LOSS AT THE SAME TIME (THIS ORG IS ONLY SETUP FOR 7 BEDS, THERE IS A FREE, UNUSED CHANNEL THAT IS NOT BEING MONITORED). NO PATIENT HARM WAS REPORTED.