ECG CABLES AND LEADSETS

Additional Manufacturer Narrative

ANALYSIS WAS PERFORMED BY REMOTE SERVICING PERSONNEL. A PHILIPS REMOTE SERVICE ENGINEER (RSE) SPOKE TO THE CUSTOMER BIOMED. BASED ON THE CONVERSATION, THERE WERE OCCASIONAL IRREGULAR ECG TRACES. A PHILIPS REMOTE SERVICE ENGINEER (RSE) SPOKE TO THE CUSTOMER BIOMEDICAL ENGINEER (BIOMED). BASED ON THE CONVERSATION, THERE WERE OCCASIONAL IRREGULAR ECG TRACES. BASED ON THE RESULTS OF THE ANALYSIS, IT WAS DETERMINED THAT THE PRODUCT HAS MALFUNCTIONED AND THE MOST LIKELY CAUSE OF THE REPORTED PROBLEM WAS A FAILURE OF THE ECG LEAD SET AND TRUNK CABLE. THE RSE ORDERED REPLACEMENT CABLES AND LEADS TO BE SENT TO THE CUSTOMER. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE REOPENED FOR FURTHER INVESTIGATION.

Description of Event or Problem

PHILIPS RECEIVED A COMPLAINT ON A LEADSET, GRABBER, IEC, OR INDICATING THEY WERE GETTING AN IRREGULAR ECG TRACE. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. NO ADVERSE EVENT WAS REPORTED.