ORG-9110A

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS HAVING INTERMITTENT SIGNAL LOSS ON MULTIPLE TRANSMITTERS. NO PATIENT HARM WAS REPORTED. THE BME IS SENDING THE DEVICE INTO NIHON KOHDEN FOR EVALUATION AND REPAIR.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

COMPLAINT SUMMARY: ON 11/15/2023, THE BIOMED REPORTED AN INTERMITTENT SIGNAL LOSS ON JUST ONE ORG (MODEL: ORG-9110A, SERIAL NUMBER: (B)(6) RECEIVER CARDS WITH MULTIPLE TRANSMITTERS. THE CUSTOMER TESTED SEVERAL OF THE ORG RECEIVER CARDS, AS WELL AS TESTED RSSI VALUES AND NOISE. ALL THE VALUES WERE CORRECT. THE CUSTOMER ISOLATED THE SIGNAL LOSS TO THIS ONE ORG THEY WOULD LIKE TO SEND THE UNIT IN FOR REPAIR. THERE WAS PATIENT INVOLVEMENT WHEN THE ISSUE OCCURRED, BUT NO REPORT OF PATIENT HARM, NO INJURY, NOR ANY ADVERSE EVENT, DUE TO THE REPORTED ISSUE. INVESTIGATION SUMMARY: THE REPORTED ISSUE WAS DUPLICATED AND CONFIRMED. REPAIR CENTER FOUND DURING EVALUATION THAT CH 4, 5, 6, AND 7 WERE NOISY AND RECOMMENDED CHANGING THE RECEIVER CARDS FOR THESE CHANNELS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. BUT BASED ON THE AVAILABLE INFORMATION, THE MOST PROBABLE ROOT CAUSE WAS CONTRIBUTED TO DEFECTIVE RECEIVER CARDS CAUSING SIGNAL LOSS. THE DEVICE WAS REPAIRED, ALL MALFUNCTIONING PARTS WERE REPLACED, AND THE UNIT WAS SHIPPED BACK TO THE CUSTOMER SUCCESSFULLY. A SERIAL NUMBER REVIEW OF THE REPORTED DEVICE (MODEL: ORG-9110A, SERIAL NUMBER: 333) DOES NOT REVEAL ADDITIONAL RELATED COMPLAINTS. COMPLAINT HISTORY REVIEW OF THE CUSTOMER'S ACCOUNT DOES NOT REVEAL TRENDS FOR SIMILAR COMPLAINTS. ATTEMPT # 1: 11/20/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: 11/22/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 3: 12/01/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS HAVING INTERMITTENT SIGNAL LOSS ON MULTIPLE TRANSMITTERS. NO PATIENT HARM WAS REPORTED. THE BME IS SENDING THE DEVICE INTO NIHON KOHDEN FOR EVALUATION AND REPAIR.

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS HAVING INTERMITTENT SIGNAL LOSS ON MULTIPLE TRANSMITTERS. NO PATIENT HARM WAS REPORTED. BME IS SENDING THE DEVICE INTO NIHON KOHDEN FOR EVALUATION AND REPAIR. 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.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS HAVING INTERMITTENT SIGNAL LOSS ON MULTIPLE TRANSMITTERS. NO PATIENT HARM WAS REPORTED. THE BME IS SENDING THE DEVICE INTO NIHON KOHDEN FOR EVALUATION AND REPAIR.