BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LC PCA HOSPIRA MEDNE

    MDR report key: 3802067 · Received February 4, 2014

    Report

    Report Number
    9615050-2014-00866
    Event Type
    Malfunction
    Date Received
    February 4, 2014
    Date of Event
    November 3, 2013
    Report Date
    December 16, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Removal / Correction Number
    FA301-02
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING, THE DEVICE ALARMED WITH AN E630 (SCREW ROTATION ERROR) ERROR CODE. THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    DURING VERIFICATION TESTING AT THE SERVICE CENTER, THE DEVICE ALARMED WITH AN E630 (SCREW ROTATION ERROR) ERROR CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72000 LC PCA HOSPIRA MEDNE 80MEA MEA HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA