BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLMA DVC V11.51 1 N

    MDR report key: 3802775 · Received February 21, 2014

    Report

    Report Number
    9615050-2014-01398
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 15, 2014
    Report Date
    January 15, 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
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING, IT WAS NOTED THAT THE DEVICE DOOR ROLLER AND DOOR ROLLER PIN WERE MISSING. 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 VERIFICATION TESTING AT THE SERVICE CENTER IT WAS NOTED THAT THE DEVICE DOOR ROLLER AND DOOR ROLLER PIN WERE MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109005 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#12097, SN (B)(4)