BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR PM PMP

    MDR report key: 3823103 · Received February 19, 2014

    Report

    Report Number
    9615050-2014-01325
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    December 1, 2013
    Report Date
    December 23, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K083019
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 FROM THE DISPOSABLE BATTERIES WAS NOTED IN THE BATTERY COMPARTMENT OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105166 GEMSTAR PM PMP 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA