BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR PAIN MGE ENG

    MDR report key: 3872524 · Received April 18, 2014

    Report

    Report Number
    9615050-2014-02805
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 20, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Removal / Correction Number
    Z-1159-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND AT POWER UP THE DEVICE ALARMED FOR 11/004 (LESS THAN 2.0 VOLT ON LITHIUM BATTERY) SERVICE CODE ALARM. THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE DEVICE HAD A 11/004 (LESS THAN 2.0 VOLTS ON LITHIUM BATTERY) SERVICE ALARM CODE. THERE WERE NO REPORT OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238987 GEMSTAR PAIN MGE ENG 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA