BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APS INPUT OUTPUT MODULE

    MDR report key: 2639284 · Received July 4, 2012

    Report

    Report Number
    1628664-2012-00340
    Event Type
    Malfunction
    Date Received
    July 4, 2012
    Date of Event
    June 8, 2012
    Report Date
    June 8, 2012
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    SMOKE WAS OBSERVED COMING FROM THE STORAGE MODULE OF THE ACCELERATOR APS. NO FLAMES WERE OBSERVED, THERE WAS NO OTHER DAMAGE OR ISSUES REPORTED. THE LINMOT BOARD, PART NUMBER 8-202279-02 WAS IDENTIFIED AS THE CAUSE, WHICH THEN CAUSED THE RESISTOR TO FAIL AND ALSO REQUIRED REPLACEMENT. THE SUPPLIER IS STILL INVESTIGATING THE ROOT CAUSE, BUT THERE IS EVIDENCE THAT THE SAME COMPONENTS ALWAYS FAILED. THE FAILURES SUGGEST A DEFECT IN THE MANUFACTURING OF THE BOARD. (B)(4). CURRENT LABELING ADVISES OPERATORS ON ELECTRICAL SAFETY AND PROVIDES INSTRUCTIONS TO FIELD SERVICE FOR REPLACING AND VERIFYING THE DRIVER BOARD AND RESISTOR. A PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE OPERATOR AT THE ACCOUNT NOTICED NO MOVEMENT ON THE X AXIS OF THE IOM ROBOT AND SMOKE COMING FROM LINMOT DRIVER BOARD ON THE APS IOM. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APS INPUT OUTPUT MODULE JQP ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 APS TUBE STORAGE MODULE, LIST 07L07-02| SERIAL (B)(4)