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. 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 OR ECG TRUNK CABLE. THE RSE ORDERED A REPLACEMENT LEAD SETS AND TRUNK CABLES TO BE SENT TO THE CUSTOMER. BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, NO FURTHER ACTION IS NECESSARY AT THIS TIME. THE DATA ENTERED IN THIS COMPLAINT RECORD WILL BE UTILIZED FOR PRODUCT QUALITY AND SAFETY IMPROVEMENTS PER THE POST MARKET SURVEILLANCE AND RISK MANAGEMENT PROCESSES. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE REOPENED FOR FURTHER INVESTIGATION. E1: REPORTING INSTITUTION PHONE #: (B)(6). REPORTER PHONE #: (B)(6).

Description of Event or Problem

PHILIPS RECEIVED A COMPLAINT ON A 5 LEAD ECG TRUNK CABLE, AAMI/IEC 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.