BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREPMATE ACCESSORY

    MDR report key: 1099751 · Received August 6, 2008

    Report

    Report Number
    1062336-2008-00006
    Event Type
    Malfunction
    Date Received
    August 6, 2008
    Date of Event
    July 8, 2008
    Report Date
    August 6, 2008
    Manufacturer
    TRIPATH IMAGING, INC.
    Product Code
    MKQ
    PMA / PMN Number
    P970018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TRIPATH IMAGING IDENTIFIED AN INCREASING TREND IN SMOKE/SPARKING EVENTS IN THE PREPMATE INSTRUMENT IN 2007 AND INITIATED AN INVESTIGATION. THE ROOT CAUSE WAS DETERMINED TO BE USER ERROR LEADING TO OVER-EXPOSURE OF THE HORIZONTAL INTERFACE BOARD TO CLEANING LIQUIDS. A MDR (1032336-2007-0003) WAS SUBMITTED IN OCT. 2007 DESCRIBING THE EVENTS AND ACTIONS. CORRECTIVE ACTIONS INCLUDED: TECHNICAL BULLETIN TO ALL CUSTOMERS REINFORCING PROPER CLEANING METHODS. ADDITION OF WARNING TO OPERATOR'S MANUAL (SUBMITTED TO FDA AS A SPECIAL SUPPLEMENT). ADDITION OF PLASTIC SHIELD INSIDE THE INSTRUMENT TO FURTHER PROTECT THE HORIZONTAL INTERFACE BOARD FROM EXPOSURE TO LIQUID (SUBMITTED IN PREPSTAIN ANNUAL REPORT DATED JUNE 30, 2008). THE INSTRUMENT INVOLVED IN THIS INCIDENT WAS ORIGINALLY MANUFACTURED IN OCT. 2001 AND WAS LAST REFURBISHED IN JANUARY, 2005. THE INSTRUMENT WAS RETURNED TO TRIPATH IMAGING FOR EVAL. IT WAS CONFIRMED THAT A ELECTRICAL SHORT CIRCUITING OF THE HORIZONTAL INTERFACE BOARD WAS THE ROOT CAUSE OF THE EVENT. THERE WAS ALSO EVIDENCE OF CLEANING SOLUTION IN THE BOTTOM OF THE UNIT. THIS INDICATES THAT THE CUSTOMER WAS PROBABLY NOT FOLLOWING INSTRUCTIONS FOR CLEANING THE INSTRUMENT WITH A DAMP CLOTH.

    Description of Event or Problem · 1

    A LAB TECH NOTICED AN ELECTRICAL BURNING SMELL AND SAW SMOKE COMING FROM THE INSTRUMENT AS WELL BURNED PARTICLES/ASH UNDERNEATH. TECH UNPLUGGED INSTRUMENT, AND THE SMOKE CEASED. THERE WAS NO DAMAGE TO THE LAB OR PERSONNEL. NO PT SAMPLES WERE LOST OR COMPROMISED IN THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREPMATE ACCESSORY CERVICAL CYTOLOGY VIAL PROCESSOR MKQ TRIPATH IMAGING, INC. 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1