BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCELERATOR APS

    MDR report key: 3946836 · Received July 21, 2014

    Report

    Report Number
    1628664-2014-00142
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FIELD SERVICE REPLACED THE BELT MOTOR ON THE I2000SR INTERFACE MODULE OF THE ACCELERATOR APS. THE BELT WAS OK FOR A WHILE BUT THEN THE MOTOR STOPPED. THE GEAR ON THE BELT WAS FOUND TO BE WORN WHICH CAUSED THE MOTOR TO STOP THEN OVERHEAT AND SMOKE. A NEW BELT RESOLVED THE ISSUE. THE MOTOR WAS STILL USABLE AFTER REPLACING THE BELT AND WAS NOT AVAILABLE FOR RETURN. THE BELTS AND MOTORS ARE COMMONLY REPLACED TO ADDRESS BELT MOVEMENT ISSUES. HISTORICAL COMPLAINT DATA WAS REVIEWED. NO ADVERSE TRENDS INVOLVING THE PARTS WERE IDENTIFIED. NO OTHER TICKETS WERE FOUND INDICATING ANY EVIDENCE OF FIRE/SMOKE/BURNING FROM THE MOTOR, PART NUMBER 8-203835-01. NO OTHER ISSUES WERE IDENTIFIED FOR THE INTERFACE MODULE THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT ISSUE. BASED ON THE AVAILABLE INFORMATION, A DEFICIENCY WAS NOT IDENTIFIED. THERE IS NO EVIDENCE THAT REASONABLY SUGGESTS A MALFUNCTION OCCURED. THE WORN GEAR ON THE BELT WAS THE ROOT CAUSE OF THE ISSUE WHICH WAS RESOLVED THROUGH NORMAL TROUBLESHOOTING PROCEDURES PROVIDED IN CURRENT LABELING.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED SMOKE COMING FROM THE SPUR MOTOR ON THE ACCELERATOR AUTOMATED PROCESSING SYSTEM (APS). SERVICE WAS DISPATCHED TO INSPECT AND REPAIR. NO FIRE OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424509 ACCELERATOR APS AUTOMATED SAMPLE HANDLING AND PROCESSING SYSTEM JQP ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1