BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEAC DENTAL SYSTEM

    MDR report key: 3495578 · Received December 2, 2013

    Report

    Report Number
    1722638-2013-00001
    Event Type
    Malfunction
    Date Received
    December 2, 2013
    Date of Event
    October 1, 2013
    Report Date
    October 31, 2013
    Manufacturer
    ASI MEDICAL, INC.
    Product Code
    EIA
    PMA / PMN Number
    K974487
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED TO U.S. FOR EVAL AND TRADE IN BY THE CUSTOMER. HOWEVER, THE CUSTOMER HAD REMOVED AND DISCARDED THE PARTS OF THE AIR TANK FROM THE CART. SO WE ARE UNABLE TO EVALUATE AND DETERMINE THE SOURCE OR CAUSE OF THE FAILURE OR IF ANY EXTERNAL PHYSICAL DAMAGE MAY HAVE BEEN DONE TO IT IN ORDER TO CAUSE THE FAILURE.

    Description of Event or Problem · 1

    THE DENTIST HAS A MODEL 2020 MOBILE SEAC DENTAL CART WITH A BUILD IN AIR COMPRESSOR AND AIR TANK. THE CART IS ELEVEN YEARS OLD AND WAS MANUFACTURED IN OCTOBER 2002. THE AIR COMPRESSOR AND AIR TANK ARE FULLY ENCLOSED INSIDE THE METAL CHASSIS OF THE CART WHICH ARE ONLY ACCESSIBLE THROUGH A SERVICE PANEL. THE CART USED A PLASTIC AIR TANK THAT BLEW APART AFTER HOURS. THERE WERE NO INJURIES AND NO PTS INVOLVED. HOWEVER, IF A SERVICE TECHNICIAN WAS WORKING ON THE CART AND THIS PROBLEM WERE TO REOCCUR IT COULD RESULT IN BODILY INJURY TO THEIR HANDS. THIS CART MODEL DESIGN WITH THE PLASTIC AIR TANK WAS DISCONTINUED IN 2004 AND THIS POTENTIAL PROBLEM EXISTS ONLY WITH CARTS MADE ON OR BEFORE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622328 SEAC DENTAL SYSTEM DENTAL UNIT EIA ASI MEDICAL, INC. 2020

    Patients

    Seq Age Sex Outcome Treatment
    1