BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR 7 THERAPY FR

    MDR report key: 2891466 · Received December 6, 2012

    Report

    Report Number
    9615050-2012-01476
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 7, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K083019
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED CHARRING. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FROM AN UNSPECIFIED AREA WITH A REPORT OF A SMOKE SMELL. NO SPECIFIC EVENT DETAILS WERE PROVIDED. DURING TESTING AT THE USER FACILITY, CHARRING WAS NOTED ON THE CONNECTION BETWEEN THE DEVICE AND THE DOCKING STATION. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT OR STAFF EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE PUMP WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMSTAR 7 THERAPY FR 80 FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA