BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTR 7 THPY ALT ST

    MDR report key: 3882726 · Received April 10, 2014

    Report

    Report Number
    9615050-2014-02595
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    February 24, 2014
    Report Date
    February 27, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING, EVIDENCE OF BURNING AND CHARRING WAS NOTED ON SOME OF THE COMPONENTS OF THE MIDDLE PRINTED CIRCUIT BOARD. THE PROBABLE CAUSE WAS A BROKEN MIDDLE PRINTED CIRCUIT BOARD. 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 OF DURING TESTING AT THE USER FACILITY THE DEVICE DID NOT HAVE AC POWER. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS NOT A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER EVIDENCE OF BURNING AND CHARRING WAS NOTED ON COME OF THE COMPONENTS OF THE MIDDLE PRINTED CIRCUIT BOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216512 GEMSTR 7 THPY ALT ST 80FRN FRN HOSPIRA COSTA RICA LTD NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA