ORG-9110A
Received Jun 22, 2026 · Event occurred May 29, 2026
Report 8030229-2026-06682 · MDR key 25585448
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 CUSTOMER REPORTED THAT THERE WAS NOISE ON THE RECEIVER CARDS FOR THIS MULTIPLE PATIENT RECEIVER (ORG). THERE IS INTERMITTENT SIGNAL LOSS ON THE TELEMETRY 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 CUSTOMER REPORTED THAT THERE WAS NOISE ON THE RECEIVER CARDS FOR THIS MULTIPLE PATIENT RECEIVER (ORG). THERE IS INTERMITTENT SIGNAL LOSS ON THE TELEMETRY TRANSMITTERS. NO PATIENT HARM WAS REPORTED.