ORG-9700A

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT THE ORG WAS IN SIGNAL LOSS WITH 9 TELEMETRY TRANSMITTERS. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: TECHNICAL SUPPORT (TS) HAD THE CUSTOMER POWER CYCLE THE ORG, WHICH DID NOT RESOLVE THE ISSUE FOR 6 OF THE 9 TRANSMITTERS. THREE OF THE TELEMETRY DEVICES WERE THEN WORKING, WITH SIX STILL SHOWING SIGNAL LOSS. THE CUSTOMER VERIFIED THAT THOSE SIX TRANSMITTERS WERE NOT BEING USED TO MONITOR PATIENTS AND WERE POWERED OFF. ONCE THE CUSTOMER POWERED ONE OF THOSE TRANSMITTERS ON TO TEST, THE SIGNAL LOSS ISSUE WAS RESOLVED. THE CUSTOMER CALLED ABOUT TWO HOURS LATER TO REPORT THAT THE SIGNAL LOSS CAME BACK AND WAS INTERMITTENT. DURING THE CALL, THERE WAS NO SIGNAL LOSS, AND THE CUSTOMER WAS HESITANT TO PERFORM TROUBLESHOOTING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED, AS NO ADDITIONAL INFORMATION WAS PROVIDED FOR THE REPORTED EVENT. THE INTERMITTENT NATURE OF THE SIGNAL LOSS EVENTS INDICATES A FEW POSSIBLE CAUSES: ENVIRONMENTAL SIGNAL INTERFERENCE OR ORG/ZM FAILURE. SERVICE HISTORY FOR THIS FACILITY SHOWS ONE EVENT AROUND THE SAME TIME UNDER TICKET 123075. ON (B)(6) 2021, THE CUSTOMER REPORTED ONE OF THESE ZM DEVICES HAD DAMAGE DUE TO WATER INTRUSION AND REQUESTED A REPLACEMENT. LATER UNDER TICKET 141102, THE CUSTOMER REQUESTED MAINTENANCE INFORMATION FOR THE ZM DEVICES. THESE TWO EVENTS INDICATE POSSIBLE ZM FAILURES. IN 2019, UNDER THREE SUCCESSIVE TICKETS (49036, 50496, 50499), THE CUSTOMER REPORTED SIGNAL LOSS EVENTS. ONE OF THE DEVICES WAS EVALUATED BY NIHON KOHDEN, WHERE THE DEVICE WAS FOUND TO BE IN A POOR STATE OF MAINTENANCE. BATTERY CONTACT CORROSION (MOISTURE) AND DIRTY PRONG WERE OBSERVED. THERE HAVE BEEN NO OTHER REPORTS FROM THIS FACILITY SINCE (B)(6) 2022. OF THE RELATED TICKETS, THERE WAS NO INDICATION OF ENVIRONMENTAL INTERFERENCE AND NO ORG FAILURE. RATHER, SOME ZM DEVICES WERE FOUND TO BE IN A POOR STATE OF MAINTENANCE, WHICH IS THEREFORE, A PROBABLE CAUSE OF THE REPORTED SIGNAL LOSS EVENTS. 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, H10 ADDITIONAL MANUFACTURER NARRATIVE.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE ORG WAS IN SIGNAL LOSS WITH 9 TELEMETRY TRANSMITTERS. TECHNICAL SUPPORT (TS) HAD THE CUSTOMER POWER CYCLE THE ORG, WHICH DID NOT RESOLVE THE ISSUE FOR 6 OF THE 9 TRANSMITTERS. THERE WAS NO PATIENT INJURY REPORTED.

Additional Manufacturer Narrative

THE CUSTOMER FOUND OUT THAT THOSE 6 UNITS HAD NO PATIENTS ON. THE CUSTOMER LATER REPORTED THAT INTERMITTENT SIGNAL LOSS IS STILL HAPPENING. THE CUSTOMER REQUESTED ONSITE SUPPORT. TS IS WORKING WITH THE CUSTOMER TO RESOLVE THE PROBLEM. 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 CUSTOMER REPORTED THAT THE ORG SHOWED 9 TELES IN SIGNAL LOSS. TECHNICAL SUPPORT (TS) ASKED THE CUSTOMER TO POWER CYCLE THE ORG AND AFTER DOING THAT ONLY 6 OF THE UNITS STILL SHOWED SIGNAL LOSS. THERE WAS NO PATIENT INJURY REPORTED.