BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLMA DVC V11.51 1 N

    MDR report key: 3111741 · Received May 7, 2013

    Report

    Report Number
    9615050-2013-01069
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 12, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFORMATION 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 INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PT INFORMATION, PUMP 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 INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200041 PLMA DVC V11.51 1 N 80FRN FRN HOSPIRA COSTA RICA LTD NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SN (B)(4)| PLUM A+ SOFTWARE MODULE, LIST #12097