ORG-9110A
Received Mar 20, 2026 · Event occurred Feb 27, 2026
Report 8030229-2026-06306 · MDR key 24648249
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
Description of Event or Problem
THE CUSTOMER REPORTED ONGOING COMMUNICATION LOSS ISSUES ON THIS ORG. THERE WAS NO PATIENT INJURY REPORTED.
Additional Manufacturer Narrative
THE CUSTOMER REPORTED ONGOING COMMUNICATION LOSS ISSUES ON THIS ORG. THERE WAS NO PATIENT INJURY 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. THE FOLLOWING FIELD CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN THE INFORMATION WERE MADE, BUT NOT PROVIDED: D10 ATTEMPT # 1: (B)(6) 2026 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 2: (B)(6) 2026 I CALLED (B)(6) TO ASK FOR MODEL AND SERIAL NUMBERS OF ANY DEVICES THE REPORTED DEVICE WAS CONNECTED OR RELATED TO. A MESSAGE WAS LEFT FOR (B)(6) TO CALL ME BACK WITH THIS INFORMATION. ATTEMPT # 3: (B)(6) 2026 I CALLED (B)(6) TO ASK FOR MODEL AND SERIAL NUMBERS OF ANY DEVICES THE REPORTED DEVICE WAS CONNECTED OR RELATED TO. A MESSAGE WAS LEFT FOR (B)(6) TO CALL ME BACK WITH THIS INFORMATION.
Additional Manufacturer Narrative
DETAILS OF COMPLAINT: THE CUSTOMER REPORTED ONGOING COMMUNICATION LOSS ISSUES ON THIS ORG. THERE WAS NO PATIENT INJURY REPORTED. INVESTIGATION SUMMARY: THE DEVICE WITH THE REPORTED ISSUE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A ROOT CAUSE COULD NOT BE ESTABLISHED. THE FOLLOWING FIELD CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN THE INFORMATION WERE MADE, BUT NOT PROVIDED: D10 ATTEMPT # 1: 03/04/2026 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 2: 03/06/2026 I CALLED DEAN TO ASK FOR MODEL AND SERIAL NUMBERS OF ANY DEVICES THE REPORTED DEVICE WAS CONNECTED OR RELATED TO. A MESSAGE WAS LEFT FOR DEAN TO CALL ME BACK WITH THIS INFORMATION. ATTEMPT # 3: 03/10/2026 I CALLED DEAN TO ASK FOR MODEL AND SERIAL NUMBERS OF ANY DEVICES THE REPORTED DEVICE WAS CONNECTED OR RELATED TO. A MESSAGE WAS LEFT FOR DEAN TO CALL ME BACK WITH THIS INFORMATION. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT. G3 DATE RECEIVED BY MANUFACTURER. G6 TYPE OF REPORT. H2 IF FOLLOW UP, WHAT TYPE? H11 ADDITIONAL MANUFACTURER NARRATIVE.
Description of Event or Problem
THE CUSTOMER REPORTED ONGOING COMMUNICATION LOSS ISSUES ON THIS ORG. THERE WAS NO PATIENT INJURY REPORTED.