BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 2890826 · Received December 31, 2012

    Report

    Report Number
    1628664-2012-00521
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    December 26, 2012
    Report Date
    December 26, 2012
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K950915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. THE CUSTOMER STATED SMOKE WAS OBSERVED FROM THE AXSYM MONITOR UPON STARTUP. ABBOTT FIELD SERVICE REPLACED THE MONITOR. TRACKING AND TRENDING IDENTIFIED NO ADVERSE TREND FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED SMOKE WAS OBSERVED FROM THE AXSYM MONITOR UPON STARTUP. ABBOTT FIELD SERVICE WAS DISPATCHED AND FOUND NO EVIDENCE OF BURNING OR SMOKE FROM THE MONITOR. FIELD SERVICE REPLACED THE MONITOR. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT OR INJURY TO PERSONNEL REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT AXSYM SYSTEM JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 AXSYM MONITOR LN 03B98-98