inforMED
MalfunctionDRG

ORG-9110A

Received Nov 5, 2025 · Event occurred Oct 13, 2025

Report 8030229-2025-05768 · MDR key 23480459

Device

Generic name

Multiple Patient Receiver

Model number

ORG-9110A

Catalog number

ORG-9110A

Lot number

NA

Product problems

  • Application Program Problem
  • Communication or Transmission Problem
  • Application Program Problem
  • Communication or Transmission Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THEY WERE UNABLE TO SEE ANY OF THE TILES ASSOCIATED WITH THIS ORG. ALL TILES WENT INTO "COMM LOSS" AT THE CENTRAL NURSE'S STATION (CNS) AND HE WAS UNABLE TO SELECT THE GROUP ASSOCIATED WITH THIS ORG. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THEY WERE UNABLE TO SEE ANY OF THE TILES ASSOCIATED WITH THIS ORG. ALL TILES WENT INTO "COMM LOSS" AT THE CENTRAL NURSE'S STATION (CNS) AND HE WAS UNABLE TO SELECT THE GROUP ASSOCIATED WITH THIS ORG. PATIENTS WERE MOVED TO OTHER RECEIVERS TO CONTINUE MONITORING. HE TRIED TO POWER-CYCLE THE ORG, BUT THE ERROR LIGHTS REMAINED ON. 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. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE ORG: CNS: MODEL #: CNS-2101, SERIAL #: (B)(6), DEVICE MANUFACTURER DATA: 01/25/2024, UNIQUE IDENTIFIER (UDI) #: (B)(4), RETURNED TO NIHON KOHDEN: MM/DD/YYYY.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THEY WERE UNABLE TO SEE ANY OF THE TILES ASSOCIATED WITH THIS ORG. ALL TILES WENT INTO "COMM LOSS" AT THE CENTRAL NURSE'S STATION (CNS) AND HE WAS UNABLE TO SELECT THE GROUP ASSOCIATED WITH THIS ORG. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THEY WERE UNABLE TO SEE ANY OF THE TILES ASSOCIATED WITH THIS ORG. ALL TILES WENT INTO "COMM LOSS" AT THE CENTRAL NURSE'S STATION (CNS) AND HE WAS UNABLE TO SELECT THE GROUP ASSOCIATED WITH THIS ORG. PATIENTS WERE MOVED TO OTHER RECEIVERS TO CONTINUE MONITORING. HE TRIED TO POWER-CYCLE THE ORG, BUT THE ERROR LIGHTS REMAINED ON. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS SENT IN FOR EVALUATION AND REPAIR IN A LATER TICKET (B)(4). THE REPORTED ISSUE WAS DUPLICATED DURING THE EVALUATION. THE EVALUATION OF THE RETURNED DEVICE SHOWED THAT THIS COMPLAINT IS CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE IS DUE TO CPU MALFUNCTION. NK WILL CONTINUE TO MONITOR AND TREND. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE ORG: CNS: MODEL #: CNS-2101. SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: 01/25/2024. UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: MM/DD/YYYY. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT. D9 DEVICE AVAILABLE FOR EVALUATION? (DATE RETURNED TO MANUFACTURER). G3 DATE RECEIVED BY MANUFACTURER. G6 TYPE OF REPORT. H2 IF FOLLOW-UP, WHAT TYPE? H6 EVENT PROBLEM AND EVALUATION CODES. H11 ADDITIONAL MANUFACTURER NARRATIVE.