ORG-9100A

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BSM) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS NOT WORKING AFTER TRYING TO SETUP HIQ VIEW FEATURE. THEY TRIED TO SETUP HIQ VIEW AND REBOOTED THE ORG AND NOW IT WILL NOT BOOT UP. 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. ADDITIONAL DEVICE INFORMATION: CONCOMITANT MEDICAL DEVICE FIELD CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED. TELEMETRY TRANSMITTER(S) MODEL: NI. SN: NI.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BSM) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS NOT WORKING AFTER TRYING TO SETUP HIQ VIEW FEATURE. THEY TRIED TO SETUP HIQ VIEW AND REBOOTED THE ORG AND NOW IT WILL NOT BOOT UP. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BSM) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS NOT BOOTING BACK UP AFTER A CONTROL REBOOT FOLLOWING AN ATTEMPT TO SET UP THE HIQ VIEW FEATURE. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: DURING THE COURSE OF TROUBLESHOOTING, NIHON KOHDEN TECHNICAL SUPPORT (NK TS) DISCOVERED THAT THE CUSTOMER WAS NOT USING THE APPROPRIATE SOFTWARE VERSION OF PUTTY AND DID NOT HAVE THE APPROPRIATE CONNECTION CABLE TO CONNECT THE ORG TO THEIR LAPTOP. THE CUSTOMER WAS ADVISED TO ADDRESS THESE ISSUES BEFORE ADDITIONAL TROUBLESHOOTING WOULD BE PERFORMED. NK TS FOLLOWED UP WITH THE CUSTOMER FOR STATUS UPDATES, BUT THEY WERE LEFT UNANSWERED. THE ROOT CAUSE IS LIKELY RELATED TO THE USE OF INCOMPATIBLE SOFTWARE AND/OR USE OF AN INCOMPATIBLE CONNECTING CABLE. THE FOLLOWING FIELDS CONTAINS NO INFORMATION (NI), AS AN ATTEMPT TO OBTAIN THE INFORMATION WAS MADE, BUT NOT PROVIDED. A2 - A6. B6 - B7. D10. ATTEMPT #1 03/14/2022 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. THE CUSTOMER RESPONDED, BUT DID NOT PROVIDE THE REQUESTED INFORMATION. ADDITIONAL DEVICE INFORMATION: D10: CONCOMITANT MEDICAL DEVICE FIELD CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED. TELEMETRY TRANSMITTERS: MODEL: NI. SN: NI. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT. G3 DATE RECEIVED BY MANUFACTURER. G6 TYPE OF REPORT. H2 IF FOLLOW-UP, WHAT TYPE? H6 EVENT PROBLEM AND EVALUATION CODES. H10 ADDITIONAL MANUFACTURER NARRATIVE.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BSM) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS NOT BOOTING BACK UP AFTER A CONTROL REBOOT FOLLOWING AN ATTEMPT TO SET UP THE HIQ VIEW FEATURE. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

UDI RELATED DATA QUALITY UPDATES. CORRECTED INFORMATION: D4 ADDITIONAL DEVICE INFORMATION / PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) #: CORRECTED THE UDI # TO INCLUDE THE 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. ADDITIONAL INFORMATION: B4 DATA OF THIS REPORT G6 TYPE OF REPORT H2 IF FOLLOW UP, WHAT TYPE?

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BSM) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS NOT BOOTING BACK UP AFTER A CONTROL REBOOT FOLLOWING AN ATTEMPT TO SET UP THE HIQ VIEW FEATURE. NO PATIENT HARM WAS REPORTED.