BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    80FRN

    MDR report key: 3894484 · Received April 25, 2014

    Report

    Report Number
    9615050-2014-02983
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 14, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K083019
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN 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

    THE DEVICE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT FROM THE CUSTOMER CONTACT OF INTERNAL BATTERY OPERATION PROBLEM. NO ADDITIONAL INFO WAS PROVIDED. THIS IS NOT A REPORTABLE MALFUNCTION. HOWEVER, 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
    252213 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA