BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFELINE EMERGENCY CART

    MDR report key: 1214146 · Received October 25, 2008

    Report

    Report Number
    1530344-2008-00003
    Event Type
    Malfunction
    Date Received
    October 25, 2008
    Date of Event
    July 28, 2008
    Report Date
    August 16, 2008
    Manufacturer
    INTERMETRO INDUSTRIES CORPORATION
    Product Code
    BZN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS RETURNED TO INTERMETRO, AND THE LATCHING MECHANISM ON THE UNIT WAS EVALUATED, AND FOUND TO BE DIFFICULT TO OPERATE. LUBRICATION OF THE MECHANISM RESULTED IN THE UNIT PERFORMING NORMALLY. A GUIDELINE FOR MAINTENANCE, INCLUDING THE PROCEDURE FOR LUBRICATING THIS MECHANISM, HAD PREVIOUSLY BEEN CREATED. IT HAS BEEN DISTRIBUTED TO USER FACILITIES, AS WELL AS DISTRIBUTORS, AND SALESFORCE FOR REVIEW AND IMPLEMENTATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THROUGH A FACILITY IN ANOTHER COUNTRY ON 8/16/08, THAT IN '08, A LEC CART HAD MALFUNCTIONED DURING A CODE, AND THE TOP COMPARTMENT COULD NOT BE READILY ACCESSED. ANOTHER UNIT WAS BROUGHT IN TO RESPOND TO THE CODE, AND THE CART WAS TAKEN OUT OF SERVICE. NO ADVERSE OUTCOME WAS REPORTED AS A RESULT, AND NO OTHER INFORMATION ON THE EVENT IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFELINE EMERGENCY CART CARDIAC CODE RESPONSE CART BZN INTERMETRO INDUSTRIES CORPORATION LEC 51 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other