BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLMA DVC V11.51 1 N

    MDR report key: 3860686 · Received April 15, 2014

    Report

    Report Number
    9615050-2014-02688
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 19, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    Z-0624-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS COMPLETE. AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVAL. 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 INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    DURING TESTING AT THE USER FACILITY, IT WAS NOTED THAT THE DEVICE DOOR ROLLER PIN WAS BROKEN. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPT FOR A REPORT OF BROKEN DOOR ROLLER PIN. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230602 PLMA DVC V11.51 1 N 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA PLUM A+ SOFTWARE MODULE, LIST #UNK, SN (B)(4)