BIOTEK 405 TS WASHER

Additional Manufacturer Narrative

INVESTIGATION IS CURRENTLY ONGOING. NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE. THEREFORE, THIS REPORT IS BEING FILED AS PART OF AGILENT'S COMMITMENT TO DUE DILIGENCE REPORTING. A1-A6: PATIENT INFORMATION HAS NOT BEEN PROVIDED BY THE USER.

Description of Event or Problem

CUSTOMER FROM GERMANY REPORTED A PROBLEM WITH BIOTEK 405 TS WASHER. THE DEVICE PRODUCED SMOKE WHEN OPERATED. THE CAUSE OF THIS ISSUE HAS NOT YET BEEN FOUND. THE SMOKE STOPPED AFTER SWITCHING OFF THE INSTRUMENT. CURRENTLY THE INSTRUMENT IS NOT WORKING. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

Description of Event or Problem

THE CUSTOMER REPORTED A PROBLEM WITH BIOTEK 405 TS WASHER. THE DEVICE PRODUCED SMOKE WHEN OPERATED; THE CUSTOMER CONFIRMED THE FOLLOWING "DURING MAINTENANCE PROGRAM THERE WAS A STRANGER SMELL". THE SMOKE STOPPED AFTER SWITCHING OFF THE INSTRUMENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE FIELD SERVICE ENGINEER (FSE) FOUND THE ULTRASONIC UNIT DEFECTIVE. THE FSE REPLACED THE ULTRASONIC UNIT AND THE TWO SEALS. THE BUFFER SWITCHING AND EVALUATION TEST PERFORMED. THE ULTRASONIC TEST WAS CARRIED OUT FOR 50 MINUTES. THE DEVICE IS WORKING PROPERLY. THE CUSTOMER IS ABLE TO CONTINUE PATIENT TESTING. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

Additional Manufacturer Narrative

A1:, A6: PATIENT INFORMATION HAS NOT BEEN PROVIDED BY THE USER.

Additional Manufacturer Narrative

CORRECTION TO MANUFACTURER REGISTRATION NUMBER, CORRECT NUMBER IS 2916205.