BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCELERATOR APS

    MDR report key: 7006307 · Received November 7, 2017

    Report

    Report Number
    1628664-2017-00427
    Event Type
    Malfunction
    Date Received
    November 7, 2017
    Report Date
    November 7, 2017
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE REQUESTED SITE VISIT BY THE ABBOTT FIELD SERVICE REPRESENTATIVE (FSR), NO EVIDENCE OF FIRE OR SMOKE ON THE SPIN DISK MOTOR WAS FOUND. THE FSR DID NOTE THAT THE BRUSHES INSIDE THE MOTOR WERE WORN. THE FSR REPLACED THE MOTOR WHICH RESOLVED THE ISSUE. A REVIEW OF THE I2000SR IM SERVICE MANUAL FOR THE I2000SR INTERFACE MODULE PROVIDES FIELD SERVICE THE PROCEDURES TO REMOVE, INSTALL, AND VERIFY THE MOTORS FOR THE I2000SR IM. A REVIEW OF ALL COMPLAINTS AGAINST THE MICROMOTORS HL149-24-90 (4X) MOTOR (PART NUMBER 8-203834-02) DID NOT IDENTIFY ANY SIMILAR COMPLAINTS OR TRENDS RELATED TO THE FAILED MOTOR. AN ADDITIONAL SEARCH FOR THE APS I2SR INT MOD (PART NUMBER 07L32-51) DID NOT YIELD ANY ADDITIONAL TICKETS RELATED TO THE FAILURE OF THE MODULE AND NO TRENDS WERE IDENTIFIED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE AUTOMATED PROCESSING SYSTEMS (APS) I2000SR INTERFACE MODULE (IM) OR THE MICROMOTORS HL149-24-90 (4X) MOTOR (PART NUMBER 8-203834-02).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BELT ON THE APS STOPPED MOVING CAUSING FRICTION WHERE THE PUCKS EXIT ONTO THE TRACK. THE CUSTOMER NOTICED A BAD SMELL AND POSSIBLE SMOKE OR DUST. THE CUSTOMER POWERED THE SPUR OFF. THERE WAS NO IMPACT TO PATIENT MANAGEMENT, USER SAFETY, OR FACILITY DAMAGE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787397 ACCELERATOR APS AUTOMATED SAMPLE HANDLING AND PROCESSING SYSTEM JQP ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1