POWERHEART G5 KIT,AUTO,DUT-INTL ENG,CPRD

Additional Manufacturer Narrative

ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE PRODUCT FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

Description of Event or Problem

COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED AN "ECG FAULT -501" ERROR MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE CUSTOMER'S REPORT WAS OBSERVED DURING REVIEW OF THE DEVICE DATA LOGS. HOWEVER, THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING INCLUDING DAILY, WEEKLY, AND MONTHLY SELF-TESTS, ON/OFF CURRENT, PATIENT AND CIRCUIT IMPEDANCE TESTING, AND SHOCK TESTING WITHOUT DUPLICATING THE CUSTOMER'S REPORT. AN INTERNAL INSPECTION FOUND NO DISCREPANCIES. THE MAIN BOARD WILL BE REPLACED AS A PRECAUTION. THE MAIN BOARD WAS SCRAPPED AFTER TESTING. THE DEVICE WILL BE RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.