BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LC PCA NEW 802.11 AB

    MDR report key: 3955433 · Received June 12, 2014

    Report

    Report Number
    9615050-2014-03965
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    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
    MN, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS COMPLETE. AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVALUATION. THE CUSTOMER CONTACT STATED THE DEVICE WILL BE REPAIRED AT THE USER FACILITY. THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    DURING PREVENTIVE MAINTENANCE TESTING AT THE USER FACILITY, THE DEVICE ALARMED WITH AN E630 (SCREW ROTATION ERROR) ERROR CODE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347126 LC PCA NEW 802.11 AB 80MEA MEA HOSPIRA COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1