BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XLM W/DATAPORT

    MDR report key: 3964094 · Received May 5, 2014

    Report

    Report Number
    9615050-2014-03226
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    January 1, 2014
    Report Date
    March 19, 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
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE DEVICE BATTERY WAS SWOLLEN. THIS WAS DUE TO A BATTERY WITH A LOSS OF CHARGING CAPACITY. LEAD ACID BATTERY OPERATION IS BASED ON AN ELECTROCHEMICAL REACTION WHICH IS AFFECTED BY TEMPERATURE CHANGES AND AGING EFFECTS OF THE BATTERY. THIS REDUCES THE DISCHARGE CAPACITY OF THE BATTERY AND MAY INCREASE THE INTERNAL TEMPERATURE DURING THE CHARGING AND DISCHARGING PROCESS. FOR HIGH INTERNAL BATTERY TEMPERATURES, THE EFFECTS MAY RESULT IN DETERIORATION OF SERVICE LIFE. THE BATTERY WAS LABELED WITH DATE CODE (B)(4). THE GEL ELECTROLYTE WAS FORMED IN (B)(4). THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT FROM THE CUSTOMER CONTACT THAT THE DEVICE DOES NOT REGISTER CUMULATIVE VOLUME. THIS DOES NOT INDICATE A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER, IT WAS NOTED THAT THE DEVICE BATTERY WAS SWOLLEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268132 PLUM XLM W/DATAPORT 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA