BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTR 7 THPY ALT ST

    MDR report key: 3853421 · Received April 4, 2014

    Report

    Report Number
    9615050-2014-02533
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 7, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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

    THE CUSTOMER CONTACT REPORTED THAT DURING PREVENTIVE MAINTENANCE TESTING AT THE USER FACILITY, LEAKAGE FROM THE DISPOSABLE BATTERIES WAS NOTED IN THE BATTERY COMPARTMENT OF THE DEVICE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205001 GEMSTR 7 THPY ALT ST 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA