ORG-9110A

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS DISPLAYING AN ERROR LIGHT, WHILE IN USE WITH PATIENTS BUT NO PATIENT HARM WAS REPORTED. BME REMOVED THE DEVICE FROM USE AND PUT A KNOWN WORKING ORG INTO USE. BME TO RETURN THIS UNIT TO NIHON KOHDEN FOR EVALUATION.

Additional Manufacturer Narrative

COMPLAINT SUMMARY: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS DISPLAYING AN ERROR LIGHT, WHILE IN USE WITH PATIENTS BUT NO PATIENT HARM WAS REPORTED. BME REMOVED THE DEVICE FROM USE AND PUT A KNOWN WORKING ORG INTO USE. BME TO RETURN THIS UNIT TO NIHON KOHDEN FOR EVALUATION. INVESTIGATION SUMMARY/EVALUATION: THE DEVICE WAS RETURNED BY THE CUSTOMER TO NK REPAIR CENTER FOR EVALUATION AND REPAIR. NK REPAIR CENTER CONFIRMED THE REPORTED ISSUE. THIS WAS ATTRIBUTED TO A SOFTWARE VERSION COMPATIBILITY ISSUE, CAUSING THE REPORTED ISSUE OF THE ERROR LIGHT TO CONSTANTLY REMAIN "ON". NK REPAIR CENTER UPDATED THE SOFTWARE TO THE LATEST COMPATIBLE SOFTWARE VERSION AND WAS SET TO "AUTO" SETTINGS. THE SYSTEM WAS INITIALIZED AFTER, AND THE RECEPTION WAS CHECKED WITH THE TEST EQUIPMENT RECEIVERS AND CNS (CENTRAL NURSING STATION), AND NO OTHER ISSUES WERE FOUND WITH THE DEVICE. WE CONFIRMED THE REPORTED ISSUE WAS ATTRIBUTED TO A SOFTWARE ISSUE, CAUSING THE ERROR LIGHT TO REMAIN "ON" AND INTERRUPT MONITORING. IT IS PROBABLE THAT THE USE OF INCOMPATIBLE AND/OR CORRUPTED SOFTWARE, IN CONJUNCTION WITH AGING AND WEAR AND TEAR TO THE DEVICE OVERTIME, CONTRIBUTED TO THE ISSUE. DURING EVALUATION AND REPAIR, THE SOFTWARE WAS UPDATED TO THE LATEST COMPATIBLE SOFTWARE VERSION, AND INITIALIZED, WHICH RESOLVED THE REPORTED ISSUE. IN THIS CASE, THE DEVICE WAS INSTALLED ON 07/30/2017 AND THE WARRANTY EXPIRED ON 07/29/2022, INDICATING THE DEVICE HAS AGED APPROXIMATELY 7 (SEVEN) YEARS. IF THE SOFTWARE IS NOT UPDATED TO THE LATEST COMPATIBLE SOFTWARE VERSION, IT CAN LEAD TO SOFTWARE ISSUES/PERFORMANCE ISSUES, ESPECIALLY IN AGING DEVICES, AS THEY ARE MORE SUSCEPTIBLE TO WEAR AND TEAR DAMAGE AND PERFORMANCE ISSUES OVERTIME. THE FOLLOWING FIELD(S) CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN THE INFORMATION WERE MADE, BUT NOT PROVIDED: D10 ATTEMPT # 1: 10/30/2024 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED.