BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTR 7 THPY ALT ST

    MDR report key: 3621885 · Received December 17, 2013

    Report

    Report Number
    9615050-2013-06049
    Event Type
    Malfunction
    Date Received
    December 17, 2013
    Date of Event
    November 1, 2013
    Report Date
    November 18, 2013
    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
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING VERIFICATION TESTING AT THE SERVICE CENTER, THE DEVICE ALARMED WITH AN 11/0044 (LESS THAN 2.0 VOLTS MEASURED ON LITHIUM BATTERY) SERVICE ALARM CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660414 GEMSTR 7 THPY ALT ST 80FRN FRN HOSPIRA COSTA RICA LTD NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA