ORG-9110A
Received May 21, 2026 · Event occurred May 7, 2026
Report 8030229-2026-06606 · MDR key 25249775
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
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) HAD A LIT ERROR LIGHT AND DROPPED THE SIGNAL TO THE ZM TRANSMITTERS. NO PATIENT HARM WAS REPORTED.
Additional Manufacturer Narrative
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE COMMUNICATION LOSS IS AFFECTING EIGHT TELEMETRY UNITS ON THEIR CNS-6201. HE WOULD LIKE TO SEND THE MULTIPLE PATIENT RECEIVER (ORG) IN FOR REPAIR BECAUSE THE ERROR LIGHT REMAINS ILLUMINATED ON THE UNIT. HE ATTEMPTED TO POWER CYCLE THE ORG, BUT THE ERROR LIGHT DID NOT CLEAR. BIOMED USED A SPARE ORG TO RESTORE MONITORING FOR THE EIGHT TELEMETRY UNITS THAT HAD GONE INTO COMMUNICATION LOSS. 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.