inforMED — FDA medical device performance lookup

Device

Generic name

Multiple Patient Receiver

Manufacturer

Nihon Kohden Corporation

Model number

ORG-9110A

Catalog 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 8 TELEMETRY UNITS ARE IN COMM-LOSS. HE NOTES THE MULTIPLE PATIENT RECEIVER (ORG) HAS 3 GREEN LIGHTS, BUT THE ERROR LIGHT IS FLASHING. TECH SUPPORT (TS) HAD THEM POWER CYCLE THE ORG FOR 5 MINUTES, AND THE ISSUE PERSISTED. TS HAD THEM CHECK THE PORT ON THE SWITCH AND HE REPORTED A SOLID GREEN LIGHT ON THE PORT. TS HAD HIM TRY ANOTHER PORT, AND HE CONFIRMED ALL LIGHTS ARE GREEN BETWEEN THE PORT AND ORG, BUT THE ERROR LIGHT IS STILL BLINKING GREEN. TS THEN CONFIRMED THE CAUSE OF THE ISSUE TO BE THE ORG AFTER TROUBLESHOOTING AND RECOMMENDED TO SEND THE UNIT IN FOR REPAIR. 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 BIOMEDICAL ENGINEER (BME) REPORTED THAT 8 TELEMETRY UNITS ARE IN COMM-LOSS. HE NOTES THE MULTIPLE PATIENT RECEIVER (ORG) HAS 3 GREEN LIGHTS, BUT THE ERROR LIGHT IS FLASHING. TECH SUPPORT (TS) HAD THEM POWER CYCLE THE ORG FOR 5 MINUTES, AND THE ISSUE PERSISTED. TS HAD THEM CHECK THE PORT ON THE SWITCH AND HE REPORTED A SOLID GREEN LIGHT ON THE PORT. TS HAD HIM TRY ANOTHER PORT, AND HE CONFIRMED ALL LIGHTS ARE GREEN BETWEEN THE PORT AND ORG, BUT THE ERROR LIGHT IS STILL BLINKING GREEN. TS THEN CONFIRMED THE CAUSE OF THE ISSUE TO BE THE ORG AFTER TROUBLESHOOTING AND RECOMMENDED TO SEND THE UNIT IN FOR REPAIR. NO PATIENT HARM WAS REPORTED.