BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFELINE EMERGENCY CART

    MDR report key: 1461766 · Received June 8, 2009

    Report

    Report Number
    1530344-2009-00001
    Event Type
    Malfunction
    Date Received
    June 8, 2009
    Date of Event
    May 7, 2009
    Report Date
    May 27, 2009
    Manufacturer
    INTERMETRO INDUSTRIES CORP.
    Product Code
    BZN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GUIDELINE FOR PRODUCT 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. THE MECHANISM WAS EVALUATED UPON RETURN AND WAS OPERATING NORMALLY; NO LUBRICATION WAS NOTED ON THE MOVING COMPONENTS OF THE MECHANISM AS PRESCRIBED IN THE MAINTENANCE PROCEDURE. IT WAS ALSO NOTED THAT ONE SMALL PLASTIC BUSHING, USED TO REDUCE SLIDING FRICTION, WAS MISSING; IT IS UNCLEAR IF THIS OCCURRED BEFORE OF AFTER REPLACEMENT. NO EXCESSIVE WEAR WAS NOTED AT THIS INTERFACE.

    Description of Event or Problem · 1

    A REPORT WAS REC'D FROM (B) (6), (B) (6) ON 5/7/09 THAT AN LEC CART HAD MALFUNCTIONED DURING A CODE, INHIBITING ACCESS TO MEDICATIONS STORED IN THE TOP COMPARTMENT OF THE CART. NO ADVERSE OUTCOME WAS REPORTED AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFELINE EMERGENCY CART BZN INTERMETRO INDUSTRIES CORP. LEC 51

    Patients

    Seq Age Sex Outcome Treatment
    1 Other