BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR PAIN MGE SNG

    MDR report key: 3894475 · Received April 25, 2014

    Report

    Report Number
    9615050-2014-02966
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 26, 2014
    Manufacturer
    HOSPIRA HOLDINGS DE COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Removal / Correction Number
    Z-1169-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING, LEAKAGE FROM THE DISPOSABLE BATTERIES WAS FOUND IN THE BATTERY COMPARTMENT AND THE PRINTED CIRCUIT BOARD OF THE DEVICE. 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 WITH A REPORT FROM THE CUSTOMER CONTACT TO REPLACE THE LITHIUM BATTERY. THIS IS NOT A REPORTABLE MALFUNCTION. DURING VERIFICATION TESTING AT THE SERVICE CENTER THE DEVICE WAS FOUND TO HAVE CORROSION IN THE BATTERY COMPARTMENT DUE TO LEAKAGE FROM THE DISPOSABLE BATTERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252185 GEMSTAR PAIN MGE SNG 80FRN FRN HOSPIRA HOLDINGS DE COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1