ORG-9110A

Additional Manufacturer Narrative

INCIDENT SUMMARY: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY SHOULD HAVE TWO TELEMETRY DEVICES (ZM) CONNECTED TO THIS MULTIPLE PATIENT RECEIVER (ORG). THEY ARE SHOWING UP ON THE CENTRAL NURSE STATION (CNS) ON THE ALL BED SCREEN BUT THE ADMIT OPTION ON THE SCREEN IS GREYED OUT. BME REMOVED ONE OF THE TELEMETRY DEVICES BUT NOW HE CANNOT SEE IT IN THE MONITOR BED SETTINGS. BME CHECKED THE CLOSET TO SEE IF THE ORG'S WERE POWERED ON AND DISCOVERED THAT THIS ORG WAS FLASHING AN ERROR LIGHT. BME REBOOTED THE ORG BUT THE ERROR LIGHT CAME BACK UP. BME CHECKED THE ETHERNET CABLES AND EVERYTHING LOOKED GOOD, HE STATED THAT THIS UNIT IS AN OLDER VERSION 03-03. NO PATIENT HARM WAS REPORTED. TROUBLESHOOTING: NIHON KOHDEN TECHNICIAN HAD THE BME CHECK THE CLOSET WHERE THE ORG'S ARE TO SEE IF THE ORG'S WERE POWERED ON AND THE BME DISCOVERED THAT THIS ORG WAS FLASHING AN ERROR LIGHT. NK TS REQUESTED THE BME TO REBOOT THE ORG BUT WHEN THE BME DID THE ERROR LIGHT CAME BACK UP. BME CHECKED THE ETHERNET CABLES AND EVERYTHING LOOKED GOOD, HE STATED THAT THIS UNIT IS AN OLDER VERSION 03-03. BME WILL RETURN THE ORG TO NIHON KOHDEN FOR EVALUATION AND SERVICE. 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(S) WERE USED IN CONJUNCTION WITH THE ORG: CNS: MODEL #: PU-6801 SERIAL #: (B)(6) DEVICE MANUFACTURER DATA: 03/09/2023 UNIQUE IDENTIFIER (UDI) #: (B)(4) RETURNED TO NIHON KOHDEN: NI. ZM TRANSMITTERS: MODEL #: ZM-531PA SERIAL #: (B)(6) DEVICE MANUFACTURER DATA: 10/15/2015 UNIQUE IDENTIFIER (UDI) # :(B)(4) RETURNED TO NIHON KOHDEN: NI. ZM TRANSMITTER: MODEL #: ZM-531PA SERIAL #: (B)(6) DEVICE MANUFACTURER DATA: 09/13/2012 UNIQUE IDENTIFIER (UDI) #: (B)(4) RETURNED TO NIHON KOHDEN: NI.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY SHOULD HAVE TWO TELEMETRY DEVICES (ZM) CONNECTED TO THIS MULTIPLE PATIENT RECEIVER (ORG). THEY ARE SHOWING UP ON THE CENTRAL NURSE STATION (CNS) ON THE ALL BED SCREEN BUT THE ADMIT OPTION ON THE SCREEN IS GREYED OUT. BME REMOVED ONE OF THE TELEMETRY DEVICES BUT NOW HE CANNOT SEE IT IN THE MONITOR BED SETTINGS. BME CHECKED THE CLOSET TO SEE IF THE ORG'S WERE POWERED ON AND DISCOVERED THAT THIS ORG WAS FLASHING AN ERROR LIGHT. BME REBOOTED THE ORG BUT THE ERROR LIGHT CAME BACK UP. BME CHECKED THE ETHERNET CABLES AND EVERYTHING LOOKED GOOD, HE STATED THAT THIS UNIT IS AN OLDER VERSION 03-03. NO PATIENT HARM WAS REPORTED.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY SHOULD HAVE TWO TELEMETRY DEVICES (ZM) CONNECTED TO THIS MULTIPLE PATIENT RECEIVER (ORG). THEY ARE SHOWING UP ON THE CENTRAL NURSE STATION (CNS) ON THE ALL BED SCREEN BUT THE ADMIT OPTION ON THE SCREEN IS GREYED OUT. BME REMOVED ONE OF THE TELEMETRY DEVICES BUT NOW HE CANNOT SEE IT IN THE MONITOR BED SETTINGS. BME CHECKED THE CLOSET TO SEE IF THE ORG'S WERE POWERED ON AND DISCOVERED THAT THIS ORG WAS FLASHING AN ERROR LIGHT. BME REBOOTED THE ORG BUT THE ERROR LIGHT CAME BACK UP. BME CHECKED THE ETHERNET CABLES AND EVERYTHING LOOKED GOOD, HE STATED THAT THIS UNIT IS AN OLDER VERSION 03-03. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

INCIDENT SUMMARY: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY SHOULD HAVE TWO TELEMETRY DEVICES (ZM) CONNECTED TO THIS MULTIPLE PATIENT RECEIVER (ORG). THEY ARE SHOWING UP ON THE CENTRAL NURSE STATION (CNS) ON THE ALL BED SCREEN BUT THE ADMIT OPTION ON THE SCREEN IS GREYED OUT. BME REMOVED ONE OF THE TELEMETRY DEVICES BUT NOW HE CANNOT SEE IT IN THE MONITOR BED SETTINGS. BME CHECKED THE CLOSET TO SEE IF THE ORG'S WERE POWERED ON AND DISCOVERED THAT THIS ORG WAS FLASHING AN ERROR LIGHT. BME REBOOTED THE ORG BUT THE ERROR LIGHT CAME BACK UP. BME CHECKED THE ETHERNET CABLES AND EVERYTHING LOOKED GOOD, HE STATED THAT THIS UNIT IS AN OLDER VERSION 03-03. NO PATIENT HARM WAS REPORTED. BME RETURNED THE DEVICE TO NIHON KOHDEN. INVESTIGATION/EVALUATION SUMMARY: THE REPORTED ISSUE WAS DUPLICATED AND CONFIRMED. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED. HOWEVER, UPON EVALUATION FROM THE REPAIR CENTER THEY FOUND THE DEVICE TO HAVE INCORRECT CONFIGURATION. THE ACTUAL CONFIGURATION WAS DIFFERENT FROM THE LABEL ON THE UNIT. THE REPAIR CENTER CORRECTED THE CONFIGURATION, INITIALIZED THE UNIT AND CHECKED RECEPTION WITH THE CNS. AS THE ISSUE COULD BE RELATED TO INITIALIZATION, IT IS LIKELY THAT THE SOFTWARE OF THE ORG COULD BE CORRUPTED OR CAUSED BY BACKUP RAM ISSUES WHICH STORE SYSTEM SETTINGS. BOTH ISSUES COULD BE RESOLVED BY INITIALIZATION. THESE ISSUES CAN OCCUR DUE TO UNGRACEFUL SHUTDOWNS, POWER OUTAGES OR USER ERROR WHILE UPGRADING THE SOFTWARE. THE UNIT WAS REPAIRED AND SHIPPED BACK TO THE CUSTOMER. A SERIAL NUMBER REVIEW OF THE REPORTED DEVICE (MODEL: ORG-9110A, SERIAL NUMBER: (B)(4)) DOES NOT REVEAL ADDITIONAL RELATED COMPLAINTS. COMPLAINT HISTORY REVIEW OF THE CUSTOMER'S ACCOUNT DOES NOT REVEAL TRENDS FOR SIMILAR COMPLAINTS. ADDITIONAL INFORMATION: B4: DATE OF THIS REPORT D9: IS THIS DEVICE AVAILABLE FOR EVALUATION? DATE RETURNED TO MANUFACTURER G3: DATE RECEIVED TO MANUFACTURER G6: TYPE OF REPORT H2: IF FOLLOW-UP, WHAT TYPE? H3: DEVICE EVALUATED BY MANUFACTURER H6: ADVERSE EVENT PROBLEM CODES. H11: ADDITIONAL MANUFACTURER NARRATIVE.