ORG-9700A

Description of Event or Problem

PLEASE REFER IMPORTER REPORT #: (B)(4).

Additional Manufacturer Narrative

OUR FIELD SPECIALIST WENT ON SITE TO INVESTIGATE THE SIGNAL LOSS BEING EXPERIENCED BY THE CUSTOMER. THE AFFECTED AREA WAS TESTED USING A SPECTRUM ANALYZER FOR EXTERNAL RADIO FREQUENCY INTERFERENCE AND NO INTERFERENCE WAS OBSERVED. THE CUSTOMER USES DISPOSABLE THIRD PARTY ECG LEAD WIRES AND ROUTINELY REUSES THEM ON DIFFERENT PTS. THE CUSTOMER ALSO DOES NOT USE NEW BATTERIES WITH EVERY PT. HE ALSO INDICATED THAT THE CUSTOMER HAS MANY OLD TRANSMITTERS, ORG MULTI-PT RECEIVERS, AND THE TELEMETRY ANTENNA SYSTEM IN THE AFFECTED AREA. THE SIGNAL LOSS IN THIS AREA WAS MITIGATED BY SWITCHING TRANSMITTERS FROM OTHER AREAS OF THE HOSPITAL TO THE AFFECTED AREA. BASED ON THE INVESTIGATION AND ASSESSMENT MADE IN THE FIELD: THE CUSTOMER ROUTINELY FOLLOWS AN UNRECOMMENDED PRACTICE OF USING NON NIHON KOHDEN ECG LEAD WIRES. THEY COMPOUND THIS ISSUE BY ROUTINELY REUSING DISPOSABLE LEAD WIRES. THESE FACTORS CONTRIBUTE TO THE OCCURRENCE OF SIGNAL LOSS. CONTINUED IN OTHER REMARKS. A REVIEW OF THE CUSTOMERS INSTALLED BASE OF TELEMETRY TRANSMITTERS INDICATES THAT THEY HAVE A SIGNIFICANT NUMBER OF AGED TRANSMITTERS AND A LARGE NUMBER OF ORG'S THAT ARE TEN YEARS OLD. THE ANTENNA SYSTEM IN THE AFFECTED AREA IS OVER SIX YEARS OF AGE. THE AGED DEVICES AND ANTENNA SYSTEM ARE FACTORS THAT CONTRIBUTE TO THE OCCURRENCE OF SIGNAL LOSS. IN ORDER TO COMPENSATE FOR THE FACTORS CONTRIBUTING TO SIGNAL LOSS THE ANTENNA SYSTEM WOULD NEED TO BE REDESIGNED. THE CUSTOMER INDICATED THAT THE SIGNAL HAS SIGNIFICANTLY DECREASED AND IS AWARE OF NK'S RECOMMENDATION TO REDESIGN THE ANTENNA SYSTEM.