BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    80 FRN

    MDR report key: 3750442 · Received December 20, 2013

    Report

    Report Number
    9615050-2013-06178
    Event Type
    Malfunction
    Date Received
    December 20, 2013
    Date of Event
    November 21, 2013
    Report Date
    November 21, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. 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 LEAKAGE WAS NOTED FROM THE DISPOSABLE BATTERIES IN THE BATTERY COMPARTMENT OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669259 80 FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA