ORG-9110A

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT A ZM TRANSMITTER WAS INTERMITTENTLY EXPERIENCING SIGNAL LOSS AND, WHEN CONNECTED, WAS DISPLAYING ARTIFACTS AND SPORADIC RESPIRATION RATE (RR) WAVEFORMS. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT A ZM TRANSMITTER WAS INTERMITTENTLY EXPERIENCING SIGNAL LOSS AND, WHEN CONNECTED, WAS DISPLAYING ARTIFACTS AND SPORADIC RESPIRATION RATE (RR) WAVEFORMS. A DUPLICATE TRANSMITTER EXHIBITED THE SAME BEHAVIOR ON THE SAME CHANNEL. TECHNICAL SUPPORT (TS) INSTRUCTED THE BME TO REASSIGN THE CHANNEL TO A DIFFERENT BED AND MOVE IT TO A DIFFERENT RECEIVER CARD ON THE MULTIPLE PATIENT RECEIVER (ORG). NORMAL OPERATION WAS RESTORED, INDICATING THE ISSUE WAS LIKELY RELATED TO THE ORG OR ONE OF ITS RECEIVER CARDS. 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 MODEL #: CNS-2101. SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: (B)(6) 2024 ((B)(6)). UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NA. ZM TRANSMITTER: MODEL #: ZM-531PA. SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: (B)(6) 2022. UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NA.