ORG-9110A

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED EXPERIENCING FREQUENT AND RECURRING COMMUNICATION LOSS ERRORS WITH THE MULTIPLE PATIENT RECEIVER (ORG) ON ALL ITS CHANNELS. 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: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE ORG: CNS-6201A MODEL #: PU-621R SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: 05/29/2015 UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: ZM TRANSMITTER MODEL #: ZM-531PA SERIAL #: (B)(6) DEVICE MANUFACTURER DATA: 10/23/2014 UNIQUE IDENTIFIER (UDI) #: (B)(4) RETURNED TO NIHON KOHDEN:. ZM TRANSMITTER MODEL #: ZM-531PA SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: 11/29/2017 UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: . ZM TRANSMITTER MODEL #: ZM-521PA SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: 03/27/2017 UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: .

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED EXPERIENCING FREQUENT AND RECURRING COMMUNICATION LOSS ERRORS WITH THE MULTIPLE PATIENT RECEIVER (ORG) ON ALL ITS CHANNELS. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED EXPERIENCING FREQUENT AND RECURRING COMMUNICATION LOSS ERRORS WITH THE MULTIPLE PATIENT RECEIVER (ORG) ON ALL ITS CHANNELS. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: THE EVALUATION OF THE RETURNED DEVICE SHOWS THAT THIS COMPLAINT IS CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE IS DUE TO FAILURE OF THE RECEIVER. THE RECEIVER WAS REPLACED, IN ADDITION, THE DEVICE WAS INITIALIZED TO FACTORY SETTINGS. NO FURTHER INVESTIGATION WILL BE PERFORMED. TRENDING WILL CONTINUE TO BE MONITORED FOR THIS DEVICE, INCIDENTS, ISSUES, AND CAUSES. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE ORG: CNS-6201A, MODEL #: PU-621R, SERIAL #: (B)(6), DEVICE MANUFACTURER DATA: 05/29/2015, UNIQUE IDENTIFIER (UDI) #: (B)(4), RETURNED TO NIHON KOHDEN: NA. ZM TRANSMITTER, MODEL #: ZM-531PA, SERIAL #: (B)(6), DEVICE MANUFACTURER DATA: 10/23/2014, UNIQUE IDENTIFIER (UDI) #: (B)(4), RETURNED TO NIHON KOHDEN: NA, ZM TRANSMITTER, MODEL #: ZM-531PA, SERIAL #: (B)(6), DEVICE MANUFACTURER DATA: 11/29/2017, UNIQUE IDENTIFIER (UDI) #: (B)(4), RETURNED TO NIHON KOHDEN: NA. ZM TRANSMITTER MODEL #: ZM-521PA, SERIAL #: (B)(6), DEVICE MANUFACTURER DATA: 03/27/2017, UNIQUE IDENTIFIER (UDI) #: (B)(4), RETURNED TO NIHON KOHDEN: NA. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT G3 DATE RECEIVED BY MANUFACTURER G6 TYPE OF REPORT H2 IF FOLLOW-UP, WHAT TYPE? H3 DEVICE EVALUATED BY MANUFACTURER H6 EVENT PROBLEM AND EVALUATION CODES H11 ADDITIONAL MANUFACTURER NARRATIVE.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED EXPERIENCING FREQUENT AND RECURRING COMMUNICATION LOSS ERRORS WITH THE MULTIPLE PATIENT RECEIVER (ORG) ON ALL ITS CHANNELS. NO PATIENT HARM WAS REPORTED.