ORG-9110A

Description of Event or Problem

THE CUSTOMER REPORTED THAT THIS UNIT WAS DISPLAYING INTERMITTENT COMMUNICATION LOSS (COMM LOSS). THERE WAS NO PATIENT INJURY REPORTED.

Additional Manufacturer Narrative

THE CUSTOMER REPORTED THAT THIS UNIT WAS DISPLAYING INTERMITTENT COMMUNICATION LOSS (COMM LOSS). ACCORDING TO THE CUSTOMER, IT WILL WORK FOR ABOUT 45 MINUTES TO AN HOUR AND THEN GO INTO COMM LOSS FOR ABOUT 1-2 MINUTES. TECHNICAL SUPPORT (TS) ADVISED THE CUSTOMER TO SWITCH THE PORT THAT THE UNIT IS PLUGGED INTO; HOWEVER, THE CUSTOMER CHOSE TO CHANGE THE ORG UNIT. TS WALKED THE CUSTOMER THROUGH THE STEPS OF CHANGING THE UNIT. THE UNIT WAS NOT IN PATIENT USE AT THE TIME. 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. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: A2 - A6 ATTEMPT # 1: 12/07/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: THE CUSTOMER REPLIED BY STATING; WE DON'T HAVE AND CAN'G GIVE OUT THE PATIENT INFORMATION. B6 ATTEMPT # 1: 12/07/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: THE CUSTOMER REPLIED BY STATING; WE DON'T HAVE AND CAN'G GIVE OUT THE PATIENT INFORMATION. B7 ATTEMPT # 1: 12/07/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: THE CUSTOMER REPLIED BY STATING; WE DON'T HAVE AND CAN'G GIVE OUT THE PATIENT INFORMATION. ADDITIONAL MODEL INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WERE USED IN CONJUNCTION WITH THE ORG: ZM TRANSMITTERS: MODEL #: ZM-531PA SERIAL #: (B)(6) DEVICE MANUFACTURER DATE: 12/13/2016 UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NO MODEL #: ZM-531PA SERIAL #: (B)(6) DEVICE MANUFACTURER DATE: 12/20/2021 UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NO

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT THIS UNIT WAS DISPLAYING INTERMITTENT COMMUNICATION LOSS (COMM LOSS). ACCORDING TO THE CUSTOMER, IT WILL WORK FOR ABOUT 45 MINUTES TO AN HOUR AND THEN GO INTO COMM LOSS FOR ABOUT 1-2 MINUTES. TECHNICAL SUPPORT (TS) ADVISED THE CUSTOMER TO SWITCH THE PORT THAT THE UNIT IS PLUGGED INTO; HOWEVER, THE CUSTOMER CHOSE TO CHANGE THE ORG UNIT. TS WALKED THE CUSTOMER THROUGH THE STEPS OF CHANGING THE UNIT. THE UNIT WAS NOT IN PATIENT USE AT THE TIME. INVESTIGATION SUMMARY: DUE TO THE CUSTOMER NOT WANTING TO SEND THE DEVICE IN FOR EVALUATION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. ADDITIONALLY, THE CUSTOMER DID NOT WANT TO PERFORM ANY ADDITIONAL TROUBLESHOOTING STEPS AND REQUESTED ASSISTANCE WITH SWAPPING OUT THE ORG WITH A SPARE TO RESOLVE THE ISSUE. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: A2 - A6 ATTEMPT # 1: 12/07/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: THE CUSTOMER REPLIED BY STATING; WE DON'T HAVE AND CAN'G GIVE OUT THE PATIENT INFORMATION. B6 ATTEMPT # 1: 12/07/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: THE CUSTOMER REPLIED BY STATING; WE DON'T HAVE AND CAN'G GIVE OUT THE PATIENT INFORMATION. B7 ATTEMPT # 1: 12/07/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: THE CUSTOMER REPLIED BY STATING; WE DON'T HAVE AND CAN'G GIVE OUT THE PATIENT INFORMATION. ADDITIONAL MODEL INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WERE USED IN CONJUNCTION WITH THE ORG: ZM TRANSMITTERS: MODEL #: ZM-531PA SERIAL #: (B)(6) DEVICE MANUFACTURER DATE: 12/13/2016 UNIQUE IDENTIFIER (UDI) #: (B)(4) RETURNED TO NIHON KOHDEN: NO. MODEL #: ZM-531PA SERIAL #: (B)(6) DEVICE MANUFACTURER DATE: 12/20/2021 UNIQUE IDENTIFIER (UDI) #: (B)(4) RETURNED TO NIHON KOHDEN: NO. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT G3 DATE RECEIVED BY MANUFACTURER G6 TYPE OF REPORT H2 IF FOLLOW UP, WHAT TYPE? H11 ADDITIONAL MANUFACTURER NARRATIVE. MANUFACTURER REFERENCES # (B)(4).

Description of Event or Problem

THE CUSTOMER REPORTED THAT THIS UNIT WAS DISPLAYING INTERMITTENT COMMUNICATION LOSS (COMM LOSS). THERE WAS NO PATIENT INJURY REPORTED.

Additional Manufacturer Narrative

**UDI RELATED DATA QUALITY UPDATES ONLY** CORRECTED INFORMATION: D4 ADDITIONAL DEVICE INFORMATION / PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) #: CORRECTED THE UDI # TO INCLUDE THE PRODUCTION IDENTIFIER (PI) INFORMATION. THIS IS A CORRECTION TO THE SUSPECT MEDICAL DEVICE INVOLVED IN THE REPORTED EVENT, SPECIFICALLY THE UNIQUE DEVICE IDENTIFIER (UDI) INFORMATION IN SECTION D OF THE FDA FORM 3500A, PER THE FDA REQUEST.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THIS UNIT WAS DISPLAYING INTERMITTENT COMMUNICATION LOSS (COMM LOSS). THERE WAS NO PATIENT INJURY REPORTED.