BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR 7 SP REFURB

    MDR report key: 3896031 · Received May 15, 2014

    Report

    Report Number
    9615050-2014-03433
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 2, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K083019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL 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 SAYING "DOES NOT RECOGNIZE MAIN BATTERIES." NO ADDITIONAL INFORMATION WAS PROVIDED. THIS DOES NOT INDICATE 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
    291343 GEMSTAR 7 SP REFURB 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA