BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XLM W/DATAPORT

    MDR report key: 3970794 · Received April 29, 2014

    Report

    Report Number
    9615050-2014-03092
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 4, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010924
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER PERFORMED TESTING AT THE USER FACILITY. DURING TESTING, THE DEVICE BATTERY WAS FOUND TO BE SWOLLEN. THIS WAS DUE TO THE BATTERY. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    DURING TESTING AT THE USER FACILITY, IT WAS NOTED THAT THE DEVICE BATTERY WAS SWOLLEN. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPT FOR AN UNSPECIFIED REASON. NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, DEVICE 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. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256116 PLUM XLM W/DATAPORT 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK