BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTR 7 THPY ALT ST

    MDR report key: 3822982 · Received February 19, 2014

    Report

    Report Number
    9615050-2014-01270
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    January 9, 2014
    Report Date
    January 13, 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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING, 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 KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    DURING VERIFICATION TESTING AT THE SERVICE CTR, THE DEVICE ALARMED WITH A 11/004 (LESS THAN 2/0 VOLTS ON LITHIUM BATTERY) SERVICE ALARM CODE UPON START UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104193 GEMSTR 7 THPY ALT ST 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA