BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR 7 THERAPY S

    MDR report key: 3912282 · Received May 13, 2014

    Report

    Report Number
    9615050-2014-03399
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    August 29, 2013
    Report Date
    August 29, 2013
    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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED ON 01/13/2012. THE 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 FOR AN UNSPECIFIED REASON. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO INDICATION OF A REPORTABLE MALFUNCTION. HOWEVER, 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
    285560 GEMSTAR 7 THERAPY S 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA