ORG-9110A

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS IN INTERMITTENT COMM LOSS BUT WAS SHOWING NO ERROR LIGHTS. THE DEVICE WAS SENT TO NKA FOR REPAIR. THE REPAIR CENTER COULD NOT DUPLICATE THE REPORTED ISSUE. HOWEVER, THEY FOUND THAT THE RECEIVER ON SLOT #6 HAD NOISY RESPIRATION AND NEEDED TO BE REPLACED. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS IN INTERMITTENT COMM LOSS BUT WAS SHOWING NO ERROR LIGHTS. THE ISSUE HAD BEEN ONGOING AND ONLY INVOLVED THIS DEVICE. THE DEVICE WAS SENT TO NKA FOR REPAIR. THE REPAIR CENTER COULD NOT DUPLICATE THE REPORTED ISSUE. HOWEVER, THEY FOUND THAT THE RECEIVER ON SLOT #6 HAD NOISY RESPIRATION AND NEEDED TO BE REPLACED. 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 #: PU-621RA. SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: 04/22/2015. UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NA. 4 ZM TRANSMITTERS: MODEL #: ZM-531PA. SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: 08/01/2022, 04/25/2022, 02/14/2017, 04/20/2015. UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NA.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS IN INTERMITTENT COMM LOSS BUT WAS SHOWING NO ERROR LIGHTS. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS IN INTERMITTENT COMM LOSS BUT WAS SHOWING NO ERROR LIGHTS. THE ISSUE HAD BEEN ONGOING AND ONLY INVOLVED THIS DEVICE. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: THE DEVICE WAS SENT TO NKA FOR REPAIR AND EVALUATION. THE REPAIR CENTER COULD NOT DUPLICATE THE REPORTED ISSUE. HOWEVER, THEY FOUND THAT THE RECEIVER ON SLOT #6 HAD NOISY RESPIRATION AND NEEDED TO BE REPLACED. THE RECEIVER MODULE WAS REPLACED, AND THE SYSTEM WAS VERIFIED FOR PROPER RECEPTION WITH THE CNS. FULL DISCLOSURE FOR ALL BEDS WAS CHECKED FOLLOWING BURN-IN TESTING. THE UNIT COMPLETED EXTENDED TESTING PER SERVICE MANUAL REQUIREMENTS AND PASSED QUALITY CONTROL PRIOR TO RELEASE. NO PATIENT HARM OR ADVERSE EVENTS WERE REPORTED. THE ROOT CAUSE OF THE NOSY SIGNAL WAS A FAULTY RECEIVER MODULE IN SLOT #6 CAUSING INTERMITTENT COMMUNICATION AND SIGNAL DEGRADATION. THE ROOT CAUSE OF THE INTERMITTENT COMMUNICATION LOSS COULD NOT BE DETERMINED. NK WILL CONTINUE TO MONITOR AND TREND. ADDITIONAL DEVICE INFORMATION: D10. CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE ORG: CNS: MODEL #: PU-621RA. SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: 04/22/2015. UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NA. 4 ZM TRANSMITTERS: MODEL #: ZM-531PA. SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: 08/01/2022, 04/25/2022, 02/14/2017, 04/20/2015. 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? H6. EVENT PROBLEM AND EVALUATION CODES. H11. ADDITIONAL MANUFACTURER NARRATIVE.