ORG-9100A

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BSM) REPORTED THAT THEY WERE EXPERIENCING SIGNAL LOSS OR INTERMITTENT SIGNAL LOSS AND WOULD APPRECIATE IT IF YOU COULD ASSIST WITH INFORMATION FOR THE ISSUE. TECH SUPPORT (TS) SUGGESTED THAT IT COULD BE AN ISSUE WITH THE MULTIPLE PATIENT RECEIVER (ORG) OR SOMETHING ALONG THE ANTENNA SYSTEM, BUT THE CUSTOMER DID NOT TROUBLESHOOT AS THEY STATED THAT THEY LOOKED AT ALL THAT ALREADY. THEY HAVE BEEN EXPERIENCING ISSUE SINCE (B)(6) 2021 AND WOULD LIKE TO GET SOMEONE OUT TO THE SITE TO RESOLVE THEIR ISSUE. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BSM) REPORTED THAT THEY WERE EXPERIENCING SIGNAL LOSS OR INTERMITTENT SIGNAL LOSS AND WOULD APPRECIATE IT IF YOU COULD ASSIST WITH INFORMATION FOR THE ISSUE. TECH SUPPORT (TS) SUGGESTED THAT IT COULD BE AN ISSUE WITH THE MULTIPLE PATIENT RECEIVER (ORG) OR SOMETHING ALONG THE ANTENNA SYSTEM, BUT THE CUSTOMER DID NOT TROUBLESHOOT AS THEY STATED THAT THEY LOOKED AT ALL THAT ALREADY. THEY HAVE BEEN EXPERIENCING ISSUE SINCE (B)(6) 2021 AND WOULD LIKE TO GET SOMEONE OUT TO THE SITE TO RESOLVE THEIR ISSUE. 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: CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE(S) WERE BEING USED IN CONJUNCTION WITH THE ORG. CENTRAL NURSE'S STATIONS MODEL: CNS-6801A. SN: (B)(4). MODEL: CNS-6801A. SN: (B)(4). MODEL: CNS-6801A. SN: (B)(4). MULTIPLE PATIENT RECEIVERS MODEL: ORG-9100A. SN: (B)(4). MODEL: ORG-9110A. SN: (B)(4). MODEL: ORG-9110A. SN: (B)(4). MODEL: ORG-9110A. SN: (B)(4). TELEMETRY TRANSMITTERS MODEL: ZM-531PA. SN: (B)(4). MODEL: ZM-540PA. SN: (B)(4). MODEL: ZM-541PA. SN: (B)(4). MODEL: ZM-541PA. SN: (B)(4).

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BSM) REPORTED THAT THEY WERE EXPERIENCING SIGNAL LOSS OR INTERMITTENT SIGNAL LOSS AND WOULD APPRECIATE IT IF YOU COULD ASSIST WITH INFORMATION FOR THE ISSUE. TECH SUPPORT (TS) SUGGESTED THAT IT COULD BE AN ISSUE WITH THE MULTIPLE PATIENT RECEIVER (ORG) OR SOMETHING ALONG THE ANTENNA SYSTEM, BUT THE CUSTOMER DID NOT TROUBLESHOOT AS THEY STATED THAT THEY LOOKED AT ALL THAT ALREADY. THEY HAVE BEEN EXPERIENCING ISSUE SINCE 12/2021 AND WOULD LIKE TO GET SOMEONE OUT TO THE SITE TO RESOLVE THEIR ISSUE. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

DETAILS OF THE COMPLAINT: THE BIOMEDICAL ENGINEER (BSM) REPORTED THAT THEY WERE EXPERIENCING SIGNAL LOSS OR INTERMITTENT SIGNAL LOSS AND WOULD APPRECIATE IT IF YOU COULD ASSIST WITH INFORMATION FOR THE ISSUE. TECH SUPPORT (TS) SUGGESTED THAT IT COULD BE AN ISSUE WITH THE MULTIPLE PATIENT RECEIVER (ORG) OR SOMETHING ALONG THE ANTENNA SYSTEM, BUT THE CUSTOMER DID NOT TROUBLESHOOT AS THEY STATED THAT THEY LOOKED AT ALL THAT ALREADY. THEY HAVE BEEN EXPERIENCING ISSUE SINCE 12/2021 AND WOULD LIKE TO GET SOMEONE OUT TO THE SITE TO RESOLVE THEIR ISSUE. NO PATIENT HARM WAS REPORTED. SERVICE REQUESTED / PERFORMED: BASED ON THE EVALUATION PERFORMED BY NK REPAIR CENTER, THE ISSUE OF SIGNAL LOSS WAS DUPLICATED, AND THE ECG BOARD WAS RECOMMENDED FOR REPLACEMENT. PHYSICAL DAMAGE WAS OBSERVED. INVESTIGATION CONCLUSION: BASED ON THE AGE OF THE DEVICE AND THE OBSERVATION OF PHYSICAL DAMAGE TO THE DEVICE, THE ROOT CAUSE FOR THE SIGNAL LOSS IS MOST LIKELY RELATED TO WEAR AND TEAR OR PHYSICAL DAMAGE TO THE TRANSMITTER INTERNAL COMPONENTS. IT IS UNLIKELY THAT THE ISSUE OCCURRED AS A RESULT OF A DEFICIENCY IN DESIGN OR MANUFACTURING.