ORG-9110A

Additional Manufacturer Narrative

THE CUSTOMER REPORTED THAT THIS ORG HAS AN INTERMITTENT SIGNAL LOSS ISSUE. ACCORDING TO THE CUSTOMER, THE TELE UNITS THAT THE ORG MONITORS WILL ALL GO INTO SIGNAL LOSS FOR A FEW MINUTES BEFORE RETURNING TO A CONNECTED STATUS. THIS IS HAPPENING 2-3 TIMES A DAY. THE CUSTOMER IS SENDING IN THE UNIT TO BE EXCHANGED. THERE WAS NO PATIENT INJURY 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. ATTEMPT # 1: ON (B)(6)2022 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: THE CUSTOMER REPLIED BY STATING; I DON'T HAVE PATIENT INFO. ALL ITEMS ARE UNKNOWN.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THIS ORG HAS AN INTERMITTENT SIGNAL LOSS ISSUE. THERE WAS NO PATIENT INJURY REPORTED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THIS ORG HAS AN INTERMITTENT SIGNAL LOSS ISSUE. THERE WAS NO PATIENT INJURY REPORTED.

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT THIS ORG HAS AN INTERMITTENT SIGNAL LOSS ISSUE. ACCORDING TO THE CUSTOMER, THE TELE UNITS THAT THE ORG MONITORS WILL ALL GO INTO SIGNAL LOSS FOR A FEW MINUTES BEFORE RETURNING TO A CONNECTED STATUS. THIS IS HAPPENING 2-3 TIMES A DAY. THE CUSTOMER IS SENDING IN THE UNIT TO BE EXCHANGED. THERE WAS NO PATIENT INJURY REPORTED. INVESTIGATION SUMMARY: THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION, ROOT CAUSE CANNOT BE DETERMINED. HOWEVER, IT SHOULD NOT BE RULED OUT THAT ENVIRONMENTAL FACTORS SPECIFIC TO THE REPORTED DEVICE ARE POTENTIAL CONTRIBUTORS TO THE SIGNAL LOSS. THE CPU BOARD UNIT WAS NOT REPLACED SINCE ITS INITIAL INSTALL ON APPROXIMATELY 02/2014 AND COULD BE A POTENTIAL CAUSE DUE TO ITS DEGRADATION FROM WEAR AND TEAR OR AGING. THE FOLLOWING FIELDS ARE NOT APPLICABLE (NA) TO THIS REPORT: THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: A2 - A6. ATTEMPT # 1: 06/28/2022 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: THE CUSTOMER REPLIED BY STATING; I DON'T HAVE PATIENT INFO. ALL ITEMS ARE UNKNOWN. B6: ATTEMPT # 1: 06/28/2022 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: THE CUSTOMER REPLIED BY STATING; I DON'T HAVE PATIENT INFO. ALL ITEMS ARE UNKNOWN. B7: ATTEMPT # 1: 06/28/2022 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: THE CUSTOMER REPLIED BY STATING; I DON'T HAVE PATIENT INFO. ALL ITEMS ARE UNKNOWN. D10: ATTEMPT # 1: 06/28/2022 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: THE CUSTOMER REPLIED BY STATING; I DON'T HAVE PATIENT INFO. ALL ITEMS ARE UNKNOWN. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT. G3 DATE RECEIVED BY MANUFACTURER. G6 TYPE OF REPORT. H2 IF FOLLOW UP, WHAT TYPE? MANUFACTURER REFERENCES # (B)(4). FOLLOW UP 001.