BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR 7 THERAPY

    MDR report key: 3832968 · Received March 26, 2014

    Report

    Report Number
    9615050-2014-02333
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    January 1, 2014
    Report Date
    February 25, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K083019
    Removal / Correction Number
    Z-1172-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING AT THE SERVICE CENTER, CORROSION WAS NOTED IN THE BATTERY COMPARTMENT AND ON THE BATTERY DOOR. THE PROBABLE CAUSE OF THE CORROSION WAS LEAKAGE FROM THE DISPOSABLE BATTERIES. THIS DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. 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 BY THE CUSTOMER CONTACT FOR A LITHIUM BATTERY REPLACEMENT. THIS IS NOT A REPORTABLE MALFUNCTION. 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
    176545 GEMSTAR 7 THERAPY 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA