ORG-9110A

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS SHOWING COMMUNICATION LOSS WITH CONNECTED TRANSMITTERS THE BME BELIEVES THE ORG HAS BAD RECEIVERS BECAUSE THE BME SWAPPED OUT THE TRANSMITTERS IN THOSE SECTORS AND IT IS STILL GETTING INTERMITTENT COMMUNICATION LOSS. NO PATIENT HARM WAS REPORTED. THE BME IS SENDING THE ORG INTO NIHON KOHDEN REPAIR CENTER. INSPECTION AND SERVICE: NIHON KOHDEN REPAIR CENTER RECEIVED THE CUSTOMER'S UNIT AND FOUND THAT FRONT CASE AND REAR ENCLOSURE HAS PHYSICAL DAMAGE. UNIT WAS TESTED AND FOUND THAT ALL 8 RECEIVERS HAD VERY BAD SIGNALS AND LOTS OF NOISE. ALL 8 RECEIVERS VERSION WAS AD AND THEY ARE A BAD VERSION. NKRC RECOMMENDS THAT THE UNIT NEEDS TO HAVE THE 8 RECIEVERS, FRONT ENCLOSURE AND REAR ENCLOSURE REPLACED OR AN EXCHANGE UNIT SHIPPED TO CUSTOMER. 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 FIELD(S) CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: ATTEMPT # 1: (B)(6) 2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: (B)(6) 2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 3: (B)(6) 2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 1: (B)(6) 2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: (B)(6) 2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 3: (B)(6) 2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 1: (B)(6) 2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: (B)(6) 2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 3: (B)(6) 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 SHOWING COMMUNICATION LOSS WITH CONNECTED TRANSMITTERS THE BME BELIEVES THE ORG HAS BAD RECEIVERS BECAUSE THE BME SWAPPED OUT THE TRANSMITTERS IN THOSE SECTORS AND IT IS STILL GETTING INTERMITTENT COMMUNICATION LOSS. NO PATIENT HARM WAS REPORTED. THE BME IS SENDING THE ORG INTO NIHON KOHDEN REPAIR CENTER.

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS SHOWING COMMUNICATION LOSS WITH CONNECTED TRANSMITTERS THE BME BELIEVES THE ORG HAS BAD RECEIVERS BECAUSE THE BME SWAPPED OUT THE TRANSMITTERS IN THOSE SECTORS AND IT IS STILL GETTING INTERMITTENT COMMUNICATION LOSS. NO PATIENT HARM WAS REPORTED. THE BME IS SENDING THE ORG INTO NIHON KOHDEN REPAIR CENTER. INSPECTION AND SERVICE: NIHON KOHDEN REPAIR CENTER RECEIVED THE CUSTOMER'S UNIT AND FOUND THAT FRONT CASE AND REAR ENCLOSURE HAS PHYSICAL DAMAGE. UNIT WAS TESTED AND FOUND THAT ALL 8 RECEIVERS HAD VERY BAD SIGNALS AND LOTS OF NOISE. ALL 8 RECEIVERS VERSION WAS AD AND THEY ARE A BAD VERSION. NKRC RECOMMENDS THAT THE UNIT NEEDS TO HAVE THE 8 RECEIVERS, FRONT ENCLOSURE AND REAR ENCLOSURE REPLACED OR AN EXCHANGE UNIT SHIPPED TO CUSTOMER. INVESTIGATION SUMMARY: THE CAUSE OF THE COMMUNICATION LOSS WAS BAD RECEIVERS. A DEFINITIVE CAUSE FOR WHY THE RECEIVERS HAD GONE BAD COULD NOT BE DETERMINED BUT POSSIBLE CAUSES INCLUDE PHYSICAL DAMAGE OR FLUID INTRUSION FROM USER MISHANDLING, POWER ISSUES FROM SITE OUTAGES OR SURGES WHICH CAN AFFECT THE CIRCUITRY OF ELECTRONIC COMPONENTS, ENVIRONMENTAL ISSUES SUCH AS ELECTROMAGNETIC RADIATION FROM OTHER DEVICES IN THE CUSTOMER'S SITE, OR WEAR-AND-TEAR WHICH DEPENDS ON THE AGE OF THE DEVICE AND FREQUENCY OF USE. A REVIEW OF THE DEVICES' SERIAL NUMBER SHOWS THAT IT IS 11 YEARS OLD AND HAS NO OTHER COMPLAINTS. DUE TO THE DEVICES' AGE, WEAR-AND-TEAR MAY BE A LIKELY CAUSE OR CONTRIBUTING FACTOR TO THE NOISE FOUND ON THE DEVICES' CHANNEL RECEIVERS.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS SHOWING COMMUNICATION LOSS WITH CONNECTED TRANSMITTERS THE BME BELIEVES THE ORG HAS BAD RECEIVERS BECAUSE THE BME SWAPPED OUT THE TRANSMITTERS IN THOSE SECTORS AND IT IS STILL GETTING INTERMITTENT COMMUNICATION LOSS. NO PATIENT HARM WAS REPORTED. THE BME IS SENDING THE ORG INTO NIHON KOHDEN REPAIR CENTER.