ORG-9110A
Received Jan 23, 2026 · Event occurred Jan 12, 2026
Report 8030229-2026-06109 · MDR key 24169176
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 HAD A POWER OUTAGE AND OUT OF ALL THEIR MULTIPLE PATIENT RECEIVERS (ORGS), ONLY THIS ONE DID NOT COME BACK ON. THERE IS A COMM LOSS ERROR. THERE IS AN ERROR LIGHT LIT ON THE UNIT, AND IT IS NOT ON THE NETWORK. NO PATIENT HARM 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 TELEMETRY TRANSMITTER MODEL: ZM-531PA SN: (B)(6) MODEL: ZM-531PA SN: (B)(6) MODEL: ZM-531PA SN: (B)(6) MODEL: ZM-531PA SN: (B)(6) MODEL: ZM-531PA SN: (B)(6) MODEL: ZM-531PA SN:(B)(6) MODEL: ZM-531PA SN:(B)(6) MODEL: ZM-531PA SN: (B)(6).
Description of Event or Problem
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY HAD A POWER OUTAGE AND OUT OF ALL THEIR MULTIPLE PATIENT RECEIVERS (ORGS), ONLY THIS ONE DID NOT COME BACK ON. THERE IS A COMM LOSS ERROR. THERE IS AN ERROR LIGHT LIT ON THE UNIT, AND IT IS NOT ON THE NETWORK. NO PATIENT HARM REPORTED.
Description of Event or Problem
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY HAD A POWER OUTAGE AND OUT OF ALL THEIR MULTIPLE PATIENT RECEIVERS (ORGS), ONLY THIS ONE DID NOT COME BACK ON. THERE IS A COMM LOSS ERROR. THERE IS AN ERROR LIGHT LIT ON THE UNIT, AND IT IS NOT ON THE NETWORK. NO PATIENT HARM REPORTED.
Additional Manufacturer Narrative
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY HAD A POWER OUTAGE AND OUT OF ALL THEIR MULTIPLE PATIENT RECEIVERS (ORGS), ONLY THIS ONE DID NOT COME BACK ON. THERE IS A COMM LOSS ERROR. THERE IS AN ERROR LIGHT LIT ON THE UNIT, AND IT IS NOT ON THE NETWORK. NO PATIENT HARM REPORTED. INVESTIGATION CONCLUSION: FOLLOWING A POWER OUTAGE, AN ORG RECEIVER DISPLAYED AN ERROR LIGHT AND WAS NOT ON THE CUSTOMER'S NETWORK. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND REPAIR. THE EVALUATION CONFIRMED THE REPORTED ERROR LIGHT AND DETERMINED THAT THE CAUSE OF THE ISSUE WAS FAULT IN THE UR-3981 CPU BOARD. AFTER REPLACEMENT OF THE MALFUNCTIONING COMPONENT, THE DEVICE PERFORMED TO MANUFACTURER'S SPECIFICATIONS. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE TELEMETRY TRANSMITTER MODEL: ZM-531PA SN: (B)(6). MODEL: ZM-531PA SN: (B)(6). MODEL: ZM-531PA SN: (B)(6). MODEL: ZM-531PA SN: (B(6). MODEL: ZM-531PA SN: (B)(6). MODEL: ZM-531PA SN: (B)(6). MODEL: ZM-531PA SN: (B)(6). MODEL: ZM-531PA SN: (B)(6). ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT D9 DEVICE AVAILABLE FOR EVALUATION G3 DATE RECEIVED BY MANUFACTURER G6 TYPE OF REPORT H2 IF FOLLOW-UP, WHAT TYPE? H3 DEVICE EVALUATED BY MANUFACTURER H6 EVENT PROBLEM AND EVALUATION CODES H11 ADDITIONAL MANUFACTURER NARRATIVE.