ORG-9110A

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) HAD LOST CONNECTION TWO TIMES THAT DAY. IT WILL COME BACK ON IF THEY RESET IT. THE UNIT IS GOING INTO COMMUNICATION LOSS, AND THEY CAN ONLY RESOLVE IT BY REBOOTING THE POWER. 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 ARE NOT APPLICABLE (NA) TO THE MDR REPORT: LOT NUMBER & EXPIRATION. DEVICE BLA NUMBER. THE FOLLOWING FIELDS CONTAINS NO INFORMATION (NI), AS AN ATTEMPT TO OBTAIN THE INFORMATION WERE MADE, BUT NONE WERE PROVIDED. ATTEMPT #1(B)(6) 2022 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #2 (B)(6) 2022 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #3 (B)(6) 2022 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. THE CUSTOMER RESPONDED BACK WITH COMPLAINT DETAILS, BUT THEY DID NOT PROVIDE THE PATIENT INFORMATION AS REQUESTED. ADDITIONAL DEVICE INFORMATION:CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE(S) WERE BEING USED IN CONJUNCTION WITH THE ORG, BUT MODEL AND SERIAL NUMBER INFORMATION WAS NOTED AS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE BUT INFORMATION WAS NOT PROVIDED FOR SOME OF THE DEVICES. CENTRAL NURSE'S STATION: MODEL: CNS-6801A. SN: (B)(4). TELEMETRY TRANSMITTER(S): MODEL: ZM-531PA. SN: NI.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) HAD LOST CONNECTION TWO TIMES THAT DAY. IT WILL COME BACK ON IF THEY RESET IT. THE UNIT IS GOING INTO COMMUNICATION LOSS, AND THEY CAN ONLY RESOLVE IT BY REBOOTING THE POWER.

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) HAD GONE INTO COMM LOSS TWO TIMES AND WOULD ONLY BE RESOLVE BY REBOOTING THE UNIT. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: THE CUSTOMER WAS SENT A LOANER SO THAT THE UNIT IN QUESTION COULD BE EVALUATED AND REPAIRED. AFTER THE CUSTOMER RECEIVED THE LOANER, THEY STATED THEY NO LONGER NEEDED TO SEND IN THEIR DEVICE AND RETURNED THE LOANER DEVICE. AS NO DEVICES WERE RETURNED FOR EVALUATION RELATING TO THIS EVENT, THE REPORTED ISSUE COULD NOT BE DUPLICATED NOR CONFIRMED. AS SUCH, A ROOT CAUSE CANNOT BE DETERMINED. THE CUSTOMER REPORTED A RECURRENCE IN COMMUNICATION LOSS IN TICKET (B)(4) WHICH WAS RESOLVED BY REBOOTING THE ORG. AS SUCH, IT IS UNLIKELY THAT THE CAUSE OF COMMUNICATION LOSS WAS RELATED TO A HARDWARE MALFUNCTION. THE ROOT CAUSE IS LIKELY ASSOCIATED TO A TEMPORARY SOFTWARE ERROR RELATED TO THE ORG'S NETWORK COMPONENTS OR SOFTWARE. A SERIAL NUMBER REVIEW OF THE REPORTED DEVICE DOES NOT REVEAL ANY ADDITIONAL RELATED COMPLAINTS. D10: CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE BEING USED IN CONJUNCTION WITH THE ORG, BUT MODEL AND SERIAL NUMBER INFORMATION IS LISTED AS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN THE INFORMATION WERE MADE BUT NOT PROVIDED FOR SOME OF THE DEVICES. CENTRAL NURSE'S STATION: MODEL: CNS-6801A. SN: (B)(6). TELEMETRY TRANSMITTERS: MODEL: ZM-531PA. SN: NI.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) HAD GONE INTO COMM LOSS TWO TIMES AND WOULD ONLY BE RESOLVE BY REBOOTING THE UNIT.

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.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) HAD GONE INTO COMM LOSS TWO TIMES AND WOULD ONLY BE RESOLVE BY REBOOTING THE UNIT.