BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFELINE EMERGENCY CART

    MDR report key: 1497351 · Received September 1, 2009

    Report

    Report Number
    1530344-2009-00003
    Event Type
    Malfunction
    Date Received
    September 1, 2009
    Date of Event
    August 6, 2009
    Report Date
    August 6, 2009
    Manufacturer
    INTERMETRO INDUSTRIES CORPORATION
    Product Code
    BZN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INTERMETRO HAS ASKED THAT THE UNIT BE RETURNED. WE ARE AWAITING A RESPONSE IF THIS WILL BE POSSIBLE. A MAINTENANCE GUIDELINE, INCLUDING THE PROCEDURE FOR LUBRICATING THIS MECHANISM, HAD PREVIOUSLY BEEN CREATED. IT HAD BEEN DISTRIBUTED TO USER FACILITIES AS WELL AS DISTRIBUTORS AND SALES FORCE FOR REVIEW AND IMPLEMENTATION. THIS MAINTENANCE GUIDELINE, ALONG WITH AN EXPLANTATION LETTER, WAS SENT IN AUGUST 2008 TO ALL KNOWN FACILITIES WHICH HAD LEC CARTS. INFORMATION WAS PROVIDED FOR USERS TO OBTAIN ADDITIONAL COPIES FOR ALL OF THEIR LEC CARTS. THE MAINTENANCE GUIDELINE WAS ALSO ATTACHED TO ALL NEW LEC CARTS AT THE MANUFACTURING FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM (B) (6) HOSPITAL, (B) (6), ON (B) (6) 2009, WITH ADDITIONAL INFORMATION PROVIDED ON 8/10/09, THAT AN LEC CART HAD MALFUNCTIONED DURING A ROUTINE INSPECTION, AND THAT THE TOP COMPARTMENT COULD NOT BE READILY ACCESSED. 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 CORPORATION LEC 53

    Patients

    Seq Age Sex Outcome Treatment
    1 Other