ECG CABLES AND LEADSETS

Description of Event or Problem

IT WAS REPORTED THAT THE 3 LEAD ECG TRUNK CABLE WAS PROVIDING INCORRECT READING. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

Additional Manufacturer Narrative

A PHILIPS FIELS SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE. THE FSE DETERMINED THE DEVICE HAS INTERMITTENT ISSUES WITH THE ECG READINGS. THE FSE CONFIRMED THAT THE LEADS WERE UNRESPONSIVE AT TIMES AND WOULD CREATE EXCESS NOISE WHEN MOVEMENT OCCURRED. IT WAS RECOMMENDED TO REPLACE THE ECG TRUNK LEAD SET (P/N 989803145071). THE LOT NUMBER OF THE FAULTY LEADS WAS NOT COLLECTED AT THE TIME OF THE FSE VISIT. THE CUSTOMER HAS SINCE DISPOSED OF THE LEADS, SO THE LOT NUMBER IS UNKNOWN. THE ECG LEADS WERE REPLACED FROM CUSTOMER STOCK. TESTS CONFIRMED THAT THE WAVEFORMS STAY CONSTANT AND FUNCTIONAL. THE DEVICE WAS OPERATIONAL. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.