BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XLD 110V LATIN AMERI

    MDR report key: 3172091 · Received June 11, 2013

    Report

    Report Number
    9615050-2013-01611
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    January 1, 2013
    Report Date
    May 27, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010924
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE DEVICE DOOR ROLLER WAS BROKEN. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FOR AN UNSPECIFIED REASON. NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, DEVICE PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, IT WAS NOTED THAT THE DEVICE DOOR ROLLER WAS BROKEN. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264818 XLD 110V LATIN AMERI 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK